Choosing a medical writing service provider
A sponsor buying medical writing is buying a complex intellectual activity whose scope moves while the work runs, from a market in which providers differ widely in what they deliver for the same brief. This topic covers why the work is bought in, what a buyer should weigh when selecting a provider, how to plan, run and review the relationship once one is chosen, how an agency selects and keeps the freelances it subcontracts to, and why the procurement method used for commodities does not work here. It is written from the buyer's side deliberately, because a writer or an agency answering a request for information is being judged against these criteria. Why a client hires a freelance covers the same relationship from the supplier's side, and freelance agreements and pricing what is then agreed.
Know why the work is outsourced at all
The buyer's problem is framed by two articles in the September 2014 issue of Medical Writing, the journal of the European Medical Writers Association: eight selection criteria proposed by Khushboo Nagdev and Ashish Agrawal of an Indian clinical research organisation, and an argument against reverse auctions by Julia Forjanic Klapproth and Douglas Fiebig of a German medical writing company, introduced by the journal's medical communication section editor. The issues of Medical Writing — September 2014 (volume 23, number 3), September 2015 (volume 24, number 3), June 2016 (volume 25, number 2), June 2017 (volume 26, number 2) and June 2023 (volume 32, number 2) — were admitted from an existing Markdown conversion without content repair; their known limitations are broken ligatures, mangled multi-column tables, interleaved page headers and footers, and figure text represented as marked text.
The pressures are structural. Declining research and development productivity, pricing pressure, shrinking profit margins, heavy competition and stricter regulatory requirements leave pharmaceutical companies looking to cut the cost and effort of bringing a drug to market, and outsourcing clinical trials and related activities — the major part of development cost — is the usual answer. The outsourcing market for drug development research reached $36.6 billion in 2011 and was projected to reach $60.8 billion by 2016. Clinical trial operations such as medical and clinical monitoring, product safety and project management, with data processing, were the predominant areas, but biostatistics, pharmacovigilance and in particular medical writing and communications rose sharply too.
Medical writing had become the fourth most frequently outsourced service, and the reason given is the pressure of preparing many high-quality documents for a quick regulatory submission and marketing authorisation within constraints of time, resource and budget. One analysis put the market for medical writing at around $700 million in 2008, most of it from outsourcing.
The growth in work has multiplied the providers, which turns selection into the problem. What works for one service does not necessarily work for another — the benchmarks for choosing a clinical trial operations provider and a medical writing provider are entirely different — and the tendencies worth naming in order to avoid them are "the bigger the better", "always used" and "going by the name".
What the buyers themselves say about the trade is scarcer, and a 2009 survey of medical communication managers at large pharmaceutical companies is the most direct evidence here. AMWA and a commercial industry-research company surveyed managers between October and December 2009, recruiting from the association's membership and the research company's client list; participation required a fee, which bought access to the resulting reports and to comparisons of a company's own data against the aggregate. Thirteen companies replied through fifteen respondents — 61% headquartered in the United States, 31% in Europe and 8% in Japan, all among the fifty largest in the industry and 62% among the twenty largest — so this is a small, self-selected and expensively assembled picture of the top of the market rather than a survey of the market. The AMWA Journal issues drawn on for this survey and for the 2011 panel that follows — volume 25, number 3 (2010), volume 26, number 2 (2011) and volume 27, number 1 (2012) — were admitted from existing Markdown conversions without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated.
The structural findings describe the organisation the outsourcing decision is made inside. Medical communication groups ran from fewer than 20 full-time equivalents at 53% of respondents to more than 40 at 13%; medical communication was usually organised into separate departments (80%); and regulatory writing and scientific publication functions were always separate from each other. The outsourcing trend was clear and one-directional: it had increased over the previous three years for 47% of respondents, and 60% expected it to increase over the next three.
The finding worth carrying into any provider decision is the tension between those expectations and the managers' own judgment of the work. Over half — 57% — said that work produced by internal staff members was generally of better quality, while on productivity the same managers rated vendors and staff as no different (61%), favouring staff (31%) or favouring vendors (8%). The poster's conclusion states the contradiction plainly: outsourcing is increasing more than decreasing despite the perception that internal work is better. Whether that reflects a real quality gap, a familiarity effect, or a cost decision taken above the managers answering is not something the survey can settle — but a buyer who expects a vendor to match internal quality by default is expecting something these managers did not report.
The full journal report of the same survey adds the document-by-document picture the summary version omits, and it is the part a buyer should read first, because it shows that the in-house and outsourced sets barely overlap. Kept almost entirely in-house were other regulatory documents such as briefing books (a median of 100% in-house), investigator's brochures and product licence applications (90%), phase 3 and phase 2 clinical study reports (82%), and phase 1 clinical study reports (70%). Manuscripts for scientific publication split evenly at 50%. Outsourced more than they were kept were slide presentations (70% outsourced), abstracts and posters (75%). And a long tail was outsourced entirely — a median of 100% — covering annual reports, book chapters, investigational new drug and investigational device exemption applications, non-IND clinical trial applications, clinical trial protocols, drug master files, educational material for health professionals and for patients or caregivers, health technology assessment dossiers, IND and IDE annual reports, marketing materials, news articles and press releases and other content for the public or investors, patient informed consent forms, and product licence annual reports and renewals.
Why the work leaves is stated plainly enough to check a provider pitch against. Almost all respondents (93%) cited resourcing constraints as the most important reason for outsourcing, with good experience of particular vendors, specialised vendor knowledge and cost the other common ones. Departments split their outsourcing between individual freelances and agencies in roughly equal proportions, although some used only agencies and others only individuals. And outsourcing has a staffing cost of its own that is easy to leave out of the comparison: respondents reported a median of 3 full-time employees, with 10th and 90th percentiles of 0.2 and 12, required to support their outsourcing effort.
The one direction the trend did not run is out of the country, and the obstacles named are about the work rather than about the price. Out-of-country vendors wrote only 2.5% of peer-reviewed manuscripts and no other document type, with no reported use of emerging-economy vendors at all — yet half of respondents expected to increase their use of out-of-country vendors over the following three years. Three quarters cited document quality problems and lack of face-to-face communication as the first or second most important obstacle. The authors point out that this runs counter to the widely held belief that medical writing work was rapidly flowing to vendors outside the United States, and it is a finding about thirteen very large companies in 2009 rather than about the industry.
Two details differ between the summary and the full report, and the full report is the one to cite. It gives the survey period as November and December 2009, and puts the proportion of managers rating in-house and vendor productivity as no different at 62%. It also notes that the survey never directly asked what overall proportion of work was outsourced, and that recruiting through one association's membership and one research company's client list biased the sample toward large companies.
A second driver sits underneath the resourcing one, and it is regulatory rather than commercial. Steven Walker and colleagues, introducing their 2016 survey of medical writers in the pharmaceutical and device industries, attribute the continuing growth in demand for medical writing in part to increasing regulation and governmental scrutiny of pharmaceutical and device companies, and note activity then running high in China and other parts of Asia in response to the volume of research there. The mechanism they name for how that demand reaches suppliers is a headcount constraint rather than a preference: in order to restrict headcounts many companies outsource writing to agencies and freelances, which is what has produced a medical communications sector they describe as worth billions of dollars. They also record what a buyer is buying into — those developing publications, presentations and regulatory documents are often highly qualified, with a background in research, medicine or education — and the evidence that it is worth buying, in a study showing that the use of professional writers was associated with more complete reporting of clinical trial results and a higher quality of written English.
A 2011 conference panel drawn from both sides of the transaction gave the same answer in more operational terms. Jeannine Hanson, a senior manager of global regulatory writing at a pharmaceutical company, explained the volume of outsourcing by a huge demand for regulatory writing and for safety documents against in-house expertise that is not always available, workload fluctuating with reprioritisation of work, acquisitions and partnerships, unplanned events and personnel issues, and by strategic decisions and the desire for continuity of service and of work. Her caution is that good vendor relationships are crucial to successful outsourcing.
Expect the choice to run on referrals and fit, not on procurement alone
What the same 2011 panel converged on, from four different vantage points, is that the selection runs on people rather than on procurement. Christina Rogers, a senior director of medical writing at a contract research organisation, framed it as logistics — writing skills, location, training requirements, and the duration or completion of a contract — and recommended needs assessment, planning, and being as flexible and proactive a service provider as possible. Alice Curry, a senior manager of medical writing at a pharmaceutical company, said that in her experience personal recommendations are vital when hiring subcontractors: preferred providers must sometimes be used, location can be a factor and exploratory work is often carried out, but referrals and personal contacts are the main drivers, because what everybody is seeking is fit between companies and individuals — and even where the needs are many, hirers prefer working with known providers.
The two contributors who had been freelance put the same thing from the other side. Mary-Margaret Lannon, a director of medical and scientific publications and a former freelance, said it is all about transparency, recommended identifying personal resources and stressed the importance of networking, noted that job boards and online professional networks were being used increasingly, and answered the agency-versus-independent question with either can work beautifully and the experience question with it depends. Kathy Spiegel, a consultancy president speaking as a current freelance, set out the contract models then in use — direct to the pharmaceutical company, through a contract research organisation, or through a third-party vendor — and the instruments, which are master service agreements, project-related statements of work, or project-related contracts, with payment hourly, by project, by a combination, or as full-time-equivalent payments, and the writer working on site, off site, or both. Her operative advice is that roles and responsibilities vary and should always be clarified ahead of time.
One exchange records the tension the arrangement never resolves. Spiegel's advice to a writer starting out is to be honest and build trust and the expertise will follow, and to consider acting as project manager for yourself; Hanson's reply, delivered as a joke, is that they say they want you to have multiple clients, but they are lying.
Judge the provider against eight criteria
Nagdev and Agrawal propose eight: the services offered, the organisation, its resources, quality, communication, the relationship, the contract and cost. The aim they set for the selection is a collaboration built on mutual respect, trust, transparency and flexibility on both sides.
Services. What a company needs differs: some seek complete assistance with scientific documents, regulatory or communications, at every stage of development; others want consultancy or partial assistance on the same documents. A niche agency can be the better option for specialised services such as publication planning, product branding, messaging, conceptualisation, quality control or training, while an agency with significant and diverse experience suits a buyer outsourcing entire clinical operations alongside specialised services.
Organisation. Among providers offering the same service, one sharing a similar corporate vision, mission and values is more likely to honour the buyer's goals, to use the intellectual capital available to it, and not to work at cross purposes. Size, turnover and years in business indicate staying power, consistency of service, reliability of response times and problem-solving capability, and assessing the leadership is worthwhile because it reflects vision, decision-making and the ability to plan. A large customer base with similar needs indicates breadth and depth of relevant experience and more creative solutions, and a provider with a record of delivering high-quality documents and expertise in overall study management is likely to succeed with or without experience in the specific therapeutic area. Continuous efforts such as white papers, webinars and a presence at conferences indicate a provider able to leverage its knowledge assets.
Resources. A buyer reasonably expects a team of highly trained writers experienced across therapeutic areas and document types, but the more useful evidence is the track record of the study manager and of the team actually assigned, their hands-on experience, the timelines and quality of previous documents, and their training and skill sets — not least because the employees named at proposal stage may not be the ones who eventually do the project. Leaders and coordinators must set and achieve the goals with adequate staff and material resources, and a well-defined team structure with independent writers, quality controllers and reviewers is what secures the quality and accuracy of the deliverables.
Quality. The buyer should establish that an appropriate quality assurance programme exists and is effectively executed: documents going through an internal review and quality control cycle, and demonstrable updated standard operating procedures, training modules, process flows and guidance documents. Ask also for the outcomes of previous audits and for client feedback on quality, adherence to timelines and overall satisfaction.
Communication. A provider willing to discuss expectations, clarify confusion and set realistic goals is likelier to deliver focused and reliable results. Content and style of communication matter in the business plan, the partnership agreement and the monitoring and evaluation systems; communications should be precise and carry everything relevant to the partners; and promptness, inviting feedback and regular follow-up show that the provider intends to complete the job. Effort spent establishing communication channels across linguistic, cultural and geographical boundaries deserves to be acknowledged.
Relationship. For a sustainable advantage the relationship should be one of equals and collaborative, with a flexible provider that adapts well to change and can therefore handle the complex issues of a dynamic global economy. Corporate culture can decide whether the relationship succeeds or fails, and positivity, transparency, integrity and honesty are what establish trust and build a long-term relationship.
Contract. Prefer a contract that is unambiguous and gives a clear understanding of expectations and commitments; an accurate, detailed, legally compliant and comprehensive proposal with a fair and accurate cost assessment aids the decision.
Cost. An agency realistic about costing, and providing sample cost estimates in the proposal, is less likely to generate changes that overrun the budget. The lowest bid is not necessarily the best option: it may mean the provider did not understand the full specification or the resources the project needs, or that hidden costs will be added later. Preferred agencies are experienced, give accurate and comprehensive estimates, and have additional processes for quality oversight including tracking time and events against money spent.
The authors also map these elements to the kind of work being bought, which is the part that stops the list becoming generic. Organisation, resources, quality, communication, relationship, contract and cost all bear on writing and reviewing; training and mentoring is judged mainly on organisation and leadership, initiatives, professional networking, the qualifications and experience of the manager or lead, awards and recognition, information technology and infrastructure, client feedback, issue log maintenance, communication and relationship attributes, the contract and cost, but not on associate numbers, attrition, years in industry or previous audit outcomes; branding, planning and strategy building and competitive intelligence and market analysis take nearly the full set; and audit compliance is judged on organisational standing, process and previous audit outcomes, turnaround time, client feedback, issue logs, adherence to processes, meeting etiquette, customer focus, the relationship attributes and cost.
Outsourcing decisions have traditionally been driven by cost, and the authors' conclusion is that the other factors need frequent and urgent consideration alongside it; applied with due diligence, the eight criteria are what produce an effective, long-term partnership rather than a cheap one.
What buyers actually ask for can be surveyed, and a 2017 conference poster did so from the provider's side of the table. Its author compared the criteria used to evaluate medical writing service providers between higher- and lower-spending pharmaceutical and biotechnology companies; fifty-two companies described what evidence they would expect to see regarding capability, and the results fell into seven categories. The finding reported is that large pharmaceutical companies followed a strict selection process in which capability counted for more than experience and qualifications alone, and the conclusion drawn is aimed at providers rather than buyers: many miss or overlook aspects of the criteria that large and small companies use, so a provider's work is to detail and organise the evidence that gives a potential client assurance. The same poster raises, without answering, whether the attributes that qualify a service provider apply equally to a freelance writer. Its framing figure — an estimate that the contract research organisation market would grow at an annual rate of 9.83% between 2014 and 2019 — is a 2017 projection rather than an outcome.
Yan Zhou's account of regulatory writing outsourced to contract research organisations in China, in the Summer 2020 AMWA Journal, weighs the same decision from a sponsor's side. The benefits Zhou lists are lower costs, greater efficiency, more flexible staffing in lean periods, a shorter overall timeline, and management teams in small companies freed for strategy and oversight, but outsourcing is treated as a double-edged sword. Confidentiality and intellectual priority are the sponsors' main worries, which is why internal or external audits at intervals are recommended; the promised savings and efficiency have to be proven in practice; providers' competence varies widely, so qualified teams are hard to screen and high performers hard to keep; and language, local site systems and laboratory tests add their own challenges. Before collaborating, assess the provider's systems, training included, its standard operating procedures, its staff's qualifications and its previous project experience. Price is not the only factor: flexibility, the reliability of systems, the stability of the provider's workforce and the feasibility of strategic development all decide success. A sponsor can buy a full package from manufacturing to late-phase development or a "buffet" of individual functions — for regulatory writing, registration studies combined with postmarketing or real-world studies, with regulatory responses, or with clinical dossier documents — and Zhou expected individualised specialty services to be preferred over one-size-fits-all providers, while noting that collaboration modes for regulatory submissions were still controversial. The Summer 2020 AMWA Journal issue (volume 35, number 2) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated.
Plan what to outsource and when, from the development plan
The procedure, as distinct from the criteria, comes from Julia Forjanic Klapproth's guide in the September 2015 issue of Medical Writing, on the medical writing business, which sets out four stages of outsourcing medical writing and updates an outsourcing guide she had published in a contract-research trade magazine in 2010. She became a medical writer in 1997, has twice been president of the association, and wrote as senior partner of a medical writing consultancy of thirteen years' standing — so this is a supplier's account of what a good buyer does, and worth reading as such.
Outsourcing medical writing is a different job from outsourcing monitoring or the conduct of a study, and Forjanic Klapproth divides it into four stages: defining what and when to outsource, finding and selecting the writing company, managing the services provided, and evaluating performance at the end of the project — on both sides. The goal she sets for the whole process is not a document delivered but a productive long-term relationship with a core team of writers who are an integral part of the clinical team. The demand is structural rather than cyclical: writing activities begin as early as the clinical development plan, run through every stage of a study's life cycle, and culminate in the clinical dossier of a common technical document and the responses to questions raised by regulators at European oral hearings or advisory committee meetings, with the regulatory focus on transparency and on pharmacovigilance strategies expanding the demand further. Her market figure for the period is a forecast compound annual growth rate of 9.83% for the global contract research organisation market between 2014 and 2019.
Once the development plan exists, almost none of the deadlines are unpredictable. A protocol is needed for each planned study, an investigator's brochure from the start of the first study and annually after that, development safety update reports throughout the programme, and a clinical study report within a year of each study completing — so, as she puts it, none of these deadlines need come as a surprise or leave teams scrambling for resource and time. The instruction is to sit down with the clinical team, walk through the development plan with them, map which documents will be outsourced and when they will be needed, repeat the exercise every six to twelve months, and keep the vendors informed of shifts in the plan in good time.
Her argument for bringing the writer in early is about the documents rather than the schedule. An experienced writer involved early makes sure the rationale, strategies and storyline of the planned development are well crafted in the early documents, and because the documents needed in a programme multiply quickly, those early ones become the core resource of text and ideas for the later ones — so getting them right reduces the time needed to write and review everything that follows.
Ask the questions that separate a specialist from a tag-on service
Many companies offer medical writing and all of them promise quality documents delivered on time, but for many it is not a core competency: the core expertise of most contract research organisations is running studies, data management or statistical analysis, and they offer writing because clients want the convenience of a single vendor running the study and supplying its documents. Forjanic Klapproth's questions are designed to find out which is which, and the answers give the choice more depth than cost alone.
Is writing a true expertise or a tag-on function? Ask how many years their medical writers have been writing and how many types of document they have written. It is breadth of experience across document types and indications that gives a writer the ability to suggest creative and effective ways to communicate an idea and present your data.
Do they propose timelines, and how detailed are they? An experienced group supplies a schedule covering every activity from kickoff to delivery of the final draft. Getting that from the writer tells you how well they understand the reality of writing, reviewing and finalising a document, whether they understand the scope and resource expected from their own side, and whether the expectations on your team's side are realistic.
What do they ask you? Good medical writers are more than collators of information. Notice whether they spot gaps in the material you supplied and ask about them, whether they point out the challenges they see in your request — the required timelines among them — and whether they make counter-suggestions for getting round those challenges. The questions show both how much experience they have and whether they are willing and able to work with you to find pragmatic solutions.
Do they want their writers to have direct access to key team members? Asking for it shows they understand that integrating the writer into the clinical team is one of the most effective ways to streamline the writing process, and that routing explanations and clarifications through a middleperson risks information being lost on the way. A writer who is a full member of the team can keep the project moving by getting what they need when they need it.
What is their system for dealing with review comments? Ask whether the company has a well-defined procedure for processing reviewer comments, whether it is practical or complicated, and how open issues will be communicated to the team.
The providers' own statements are the answers a buyer receives before asking, and those printed for AMWA's 2020 conference in the Spring 2021 AMWA Journal show what each chooses to claim. Synchrogenix, Certara's regulatory science division, offered regulatory strategy, document authoring, medical communications and publications, and operations, and counted its writers' output over five years — over 200 chemistry, manufacturing and controls documents, 350 nonclinical documents and nearly 5,000 clinical documents. Thera-Business Consulting claimed more than 20 years in medical research and writing, expertise in regulatory documents, systematic reviews and meta-analyses, postmarket surveillance and implementation of the EU Medical Device Regulation, and more than 500 projects for device and pharmaceutical companies and government health agencies. Whitsell Innovations described itself as a woman-owned boutique whose writers mostly hold doctorates and who integrate with the client's team, and advertised that all its employees work remotely. Trilogy Writing & Consulting presented itself as specialists in clinical and nonclinical regulatory documentation, with more than 65 writers in Europe and North America over 18 years, writing for a readability that shortens review and approval, with a dedicated-team approach meant to cut production time and keep continuity across a development programme. None of the four describes how it handles review comments, which is the question left to ask. The Spring 2021 AMWA Journal issue (volume 36, number 1) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated.
Give the bidders enough to bid on
Half of a meaningful response to a request for proposal is the information the buyer put into it, and the instruction here is to be realistic rather than aspirational. If your procedures say two drafts and a final version but no team in the company's history has ever achieved that, a vendor reaching the third draft will need a change order, and that is the buyer's doing. So tell them how many rounds of review your company usually has and therefore how many drafts are likely to be needed; how many reviewers will be involved in each round, and whether their comments will be consolidated before they reach the writer or by the writer; whether the quality control check is theirs or an internal group's; and whether they are to prepare the appendices of a report, or to publish it electronically as a single consolidated file. A request that defines the project as "the writing of the clinical part of a common technical document" is, in her phrase, like asking the provider how long a piece of string is. Understanding exactly what is being outsourced helps the vendor bid realistically and tells the buyer what they are actually buying.
Time is the other input the buyer controls, and too little of it is the commonest cause of trouble. A 2008 survey of the sector found that most pharmaceutical companies gave contract research organisations ten working days and limited information to prepare their proposals, and she reports having seen requests with three to five days' turnaround. Bidders with too little time supply less information and standardised responses, which tells the buyer less about what distinguishes one provider from another; giving them time to ask questions, get answers and digest them produces more meaningful information to choose on. Her recommendation is to treat the process as the occasion for both sides to get to know each other — meet the vendors you are interested in, including their lead writers, together with the clinical lead from the team they would work with, ask about their experience as writers, why they think they have the skills for the documents you need and how they measure their own success, and watch how well the two sides communicate and negotiate.
The bidder's half of the same transaction is set out in responding to a request for proposal, written for trainee agency writers. Its most useful point for a buyer is what the vendor's team is reading the documentation for: not only the scope but what the client does not need told, since a client is unlikely to want a full explanation of the pharmacokinetics of a compound they have themselves spent years developing, and what often decides the award is the creativity and innovation a partnership is expected to bring rather than a demonstration of knowledge the buyer already has.
Manage the writer as a member of the team rather than as a supplier
Forjanic Klapproth's formulation of the management stage is that outsourced providers in general, and medical writers in particular, should be part of the family and not just one of the servants. Writers are often not invited to strategic meetings with management or key opinion leaders, which leaves them out of the loop on background, decisions and strategy — and a writer who never hears the discussion of the study or the product cannot understand the choices well enough to communicate their implications accurately. Explaining the rationale and the strategy matters as much in a clinical study protocol as in the summaries of a clinical dossier, and a writer who understands the argument behind the decisions can suggest how best to build the information into a coherent story. Writers who have worked on a programme for some time also bring insights from across studies and documents, and may see gaps in reasoning or details that matter to a decision if they are in the room when it is made.
What that requires of the buyer is four concrete things and a company culture that teaches internal teams to embrace their external members. Give the writer all relevant information as soon as it becomes available, because a decision taken or data arriving after a section is written costs money and time that need not have been spent. Hold regular team meetings covering the status of the timelines for every deliverable — due dates for tables, figures and listings, input from team members, the effect on upcoming drafts — as well as changes in strategy and new information. Include all contractors in those meetings rather than meeting each provider separately, because separate meetings slow communication and increase the risk that not all information reaches everyone. And listen to the external providers: there is no point hiring specialists and then not taking their advice on planning, coordinating and performing the writing. Her suggestion for the start of a new relationship is a pilot — a small document or a well-defined series of them — so that both sides learn how to work together and the buyer can see whether the writers fit the clinical teams they will support.
Once the project is let, Zhou describes the division of labour between the two sides. The sponsor drafts the first version of each document's synopsis; the provider develops the synopses into full documents, coordinates the review cycles, incorporates comments into the intermediate versions and produces the final ones; and the sponsor approves the final versions and controls quality and, outside technical areas such as pharmacokinetics, directs resources from the project's key opinion leaders, maintains the collaborative relationships and acts as gatekeeper for the milestones on the critical path.
Evaluate both sides at the end of the project
The model to avoid is one designed to find the cheapest bidder one document at a time. Clinical teams benefit from having the same writers across several or all of a programme's documents: the writer becomes familiar with the background and strategy of the product, comes to understand the dynamics of the team and works more efficiently with it, and accumulates knowledge across documents so that later ones are consistent with earlier ones. If a writer or group of writers is good, keeping them on the programme is in everyone's interest, much as the clinical lead or the statistician would be kept.
The end-of-project review is what decides whether to continue, and it is explicitly two-sided. Meet the key clinical team members and the medical writer, share and discuss how well the collaboration worked, prepare a list of what both sides felt worked well and what needs improvement, and work out together how to resolve the areas that were bumpy. The instruction to listen to the writer's half of that has a diagnosis behind it: many writing projects spiral out of control because the team cannot give the writer clear instructions, usually through divided opinions within the company, poor internal communication or a lack of leadership in the clinical team, and the writer receives mixed messages about content and deadlines. To save face, internal groups often blame the external provider rather than acknowledge a failure in their own team dynamics — and a good writer already familiar with the product and the company's processes is then lost for a reason that may have had nothing to do with them.
Two pieces of evidence support doing it formally. A 2009 survey found the four relationship management tools rated moderately to highly effective were negotiating a relationship management plan with the provider, co-developing performance metrics with the provider, conducting periodic lessons-learned reviews with the provider, and allowing the provider to use its own standard operating procedures once the sponsor has reviewed them for adequacy. And when key performance indicators are developed, they should measure the buyer's own group as well: it is not enough to record that a draft of a report was late, because scrutiny may show that every draft was delivered within the predefined turnaround for the writing activities and that it was the delivery of source material that skewed the timeline.
Her conclusion states what is being selected for. Successful outsourcing means choosing medical writers who understand what each document needs, who are proficient coordinators, and who will challenge the clinical team to present a clear, well-argued story; it hinges on developing a good relationship with a vendor and should aim at a long-term commitment; and what that returns is time and money saved at all stages of the development programme.
Select, onboard and keep a freelance as an agency
An agency that subcontracts to freelances is a buyer too, and one agency's procedure for it runs from selection through onboarding to retention. Namrata Singh and Shruti Shah, both employed by the medical communication company Turacoz, which Singh founded after starting out as a freelance, set it out in EMWA's June 2023 freelancing issue of Medical Writing as a proposed general process rather than an industry standard. Many agencies already have discrete policies for outsourcing to freelances, and these differ with the nature of the engagement: a freelance on a retainer may go through a different process from one engaged project by project. What the agency weighs in deciding to use a freelance at all is in working through agencies and recruiters.
Selection begins with an advert posted on one or more freelance networking websites or on social media such as LinkedIn, and it does not rest on experience and referrals alone: the agency may set assignments testing technical and writing skills, followed by a one-to-one interview, and may ask for samples of work from previous projects. An assessment whose material the agency plans to use may be paid, and in that case the terms are conveyed at the beginning, before the assignment is shared. The two points the authors weight equally and most heavily are the freelance's capability and expertise, and feedback or a referral from independent sources that can validate the freelance's work. A thorough background check follows — educational qualifications, past experience with relevant work samples, referrals for feedback on earlier assignments, current engagements — and then a signed confidentiality agreement. For transparency, what is expected of the freelance and how they will be paid, by project or by milestone, are charted at the beginning, and the administrative record is set up: a unique identification code for the freelance, bank account and tax information, an address for correspondence and an alternative contact number for emergencies.
Onboarding to a project is where the agency's own client first meets the freelance. The authors' preference is to introduce the writer adequately to the technical team and, where the project needs it, to the client team — ideally during the project initiation call, so that the client's confidence and trust in the writer are gained early. Where that is not feasible, brief the freelance adequately and give access to all source materials, call recordings included, so that the transfer of project knowledge is complete. Client data security is handled technically: most agencies use a dedicated interface such as a project collaboration system to which the freelance has restricted access. Open communication, the right expectations and treating the freelance as an extension of the in-house team are what they name as making the engagement succeed.
Feedback is the retention mechanism, and it covers both the quality of the deliverables and the timeliness of delivery. Many agencies run a five-star rating system that rewards a freelance with newer projects and appropriate incentives, and many invest in an online real-time dashboard holding every freelance's experience, hourly rates, availability and feedback received, from which the right freelance is chosen for the next job.
Keeping talented freelances, on their account, depends on treating them well, and acknowledging the freelance's part in the successful delivery of a project matters as much as passing on the client's feedback. Their etiquette has three items. Show respect and empathy: check the freelance's availability before assigning a project, and accept that they may have to turn one down because of other commitments. Never delay payment, or where a delay is likely, say so in advance and be transparent; payment can be per draft or per deliverable, as both sides agree before the project starts. And keep in touch regularly — simple greetings on holidays and special days, and involving freelances in team gatherings and outings as an extension of the internal team. Their conclusion restates the frame: an agency outsourcing to freelances needs a robust policy and process for selecting the right freelance for each project, and the practices of empathy and active listening for keeping them.
How an agency trains and audits the freelances it uses is a weak point the agency sector has named itself. The Global Publication Survey had revealed gaps in how agencies trained, monitored and audited freelancers, which could expose agencies and their clients to compliance risks; the proposed answer was for agencies to share best practices for identifying, training, monitoring and auditing freelancers and for becoming a preferred client, to collaborate with freelancers so that they gain insight into agency concerns and selection criteria, to draft a best-practices checklist, to invite the European and American writers' associations — which have high freelance memberships — to comment on the draft, and to make the checklist readily accessible to agencies, clients and freelancers alike so that each group knows what is being proposed.
Do not buy a complex service by reverse auction
A reverse auction, or e-auction, has competing suppliers bid against each other to drive prices down for what a buyer wants to purchase. They are not new in procurement — they date from the 1990s and have been researched extensively — and used in the right scenario they work well. The research describes that scenario clearly: the product or service is simple, well defined, non-strategic for the buyer and requires little collaboration between buyer and supplier; several suppliers offer it with the capacity and skill to do it well; there is little variance among supplier capabilities, so the bidders are comparable; and the scope can be specified precisely, with a thorough and unambiguous description of all the requirements. One article calls specifiability the most important criterion of all.
Medical writing fails every one of them. Writing a clinical study protocol, a study report or a Module 2.7 summary is a complex intellectual activity involving several stakeholders interacting collaboratively; the documents are part of the company's strategic clinical development programme; the quality of what different providers produce varies widely; and it is extremely difficult for a sponsor to give a thorough and unambiguous description of the requirements, because these documents are moving targets that change over the course of the project. That movement is not a defect in the specification but the nature of crafting a team-authored strategic document, and pretending in advance that the work can be contained to a minimal effort misreads what producing one takes.
The arguments advanced for auctioning them do not survive contact with the practice. The claim that an auction gives the buyer an overview of rates and a baseline for pricing ignores that the buyer already has the baseline once the original cost proposals arrive — unless suppliers routinely inflate bids, the opening proposals already show a cross-section of market rates, and there is no need to have suppliers reduce them on no further information than that another supplier is more desperate. Forcing suppliers into auctions may produce the inflation it assumes, since a bidder needs room to come down and to look like a good sport.
The claim that auctions save the weeks a traditional negotiation takes rests on treating the price drop as a negotiation, and it is not one. In a negotiation the supplier asks what price the buyer is aiming for, finds out more about the project and why the expectation is lower, and looks for efficiencies or shifted priorities that reduce the price while still delivering what the buyer needs most; the two sides discuss scope and conditions, the supplier explains what the proposed resources are for, and the buyer comes away understanding what the price is built on and able to influence which resources are in the package. The negotiation is also the occasion on which both sides assess the moving-target aspects that a specification cannot easily describe. An auction has none of that: no exchange of ideas to elucidate scope and no compromise reached through discussion, only a request that suppliers reduce prices for no reason other than the fear of not getting the job — which also implies that the price they submitted did not reflect the value of the service. Since it is not a negotiation, it cannot shorten one either, because negotiating remains a separate activity still to be done.
The saving itself may be illusory once the whole equation is counted. The auction process has costs of its own — software to buy, develop and maintain, and management time — and against those sits the risk that a supplier undercuts its desired price to win the bid knowing it can recoup through change orders later, at a point when the buyer is not in a position to restart procurement and switch suppliers. Squeezing suppliers on price means they squeeze on service, which is a zero-sum equation for firms with small cost-to-profit ratios; the reduced service need not be deficient in itself, but aspects overlooked because no negotiation took place may prove insufficient later in the context of the clinical programme, at additional expense.
The authors' own experience supplies the evidence that the bids are not comparable. Their company participates in auctions, because they increasingly form part of request-for-information processes, but on principle never reduces its opening bid: the price is derived from a realistic assessment of the scope indicated, and twelve years of experience shows their bids and their costs to be within 5% of each other on average, so absent new information there is no logical reason to move. They have watched other companies in the same auction drop to a fraction of that price. A discrepancy that large can only mean that the bidders understood the scope differently, because the specification was poor, or that they understood differently what the same scope requires, because their experience differs — and in either case the bids are not comparable and it would be folly to expect the low bidder to provide the same service as the high one.
Buyers say the auction supplies only one part of the equation and that information on experience and expertise distinguishes the suppliers. If so, the authors' proposal follows directly: compare the starting bids, combine them with what is known about experience and expertise, short-list two or three companies, and hold a real negotiation with those. That saves the time spent preparing for and running auctions and the cost of the software, management and maintenance behind them. The section editor's framing of the same point is a car buyer emailing four manufacturers to run an auction on price alone — comparing apples with oranges and expecting them to compete on price — and her warning is that the practice is taking hold in medical writing and threatens freelances and companies alike.
What reverse auctions do suit is worth keeping beside the argument, because the objection is to their misapplication rather than to the tool: goods of low complexity easily understood by both sides, bulk items and goods manufactured to an agreed standard, items that are non-strategic, purchases featuring little collaboration, goods with little variance among supplier capabilities, and goods with enough suppliers able to deliver.