CRO Medical Writing & Role of a Writer

A Medical writer plays a prominent role in writing various non-clinical and clinical documents related to drug approval from health authorities, in order to bring it to the market for making them accessible to the customers. Medical writer needs to produce high quality documents in a short time. Client pharma companies deal with the production and testing of drugs, but presenting this information to the HA is crucial and lies in the hands of the medical writer.

Many of the medical writing projects follow basic end to end steps, which typically start off with a kick-off meeting. For large or complicated projects, the internal team should first arrange and meet for the internal kick-off meeting so that the whole team is on the same page when client introductions are made. This helps every member understand the client requirements, which in turn gives the client the confidence that the team is well organized and understands the project.

The most important essential aspect for both the medical writers and the client  are the ‘Expectations’, which should be outlined to the extent possible before actual writing is even initiated; which include:

  • How many drafts will there be?
  • How much input will the client want to provide?
  • How often will the client provide input?

It is also important to discuss with the client, the list of reviewers from different line functions (i.e. statistician [would assist in the statistical part], DMPK expert [Drug Metabolism and Pharmacokinetics, would assist in the PK part; etc.]).

The respective timelines should also be discussed with the client:

  • Database lock (DBL) point or data cut-off date, as applicable
  • Availability of final source documents
  • Date  by when client wants the drafts
  • Date by when client wants the final deliverable

The medical writing team should work within the realistic timelines to ensure that there is no delay from their end at any instance. Usually there are one or two draft deliverables, followed by the final client deliverable document. Mostly comprehensive templates and the corresponding source documents are provided by the client, after which medical writer needs to add relevant information into the corresponding sections of the working template.

Here its actually not the matter of copy and pasting, rather it requires regulatory knowledge (for example, knowing what information is required in the efficacy section of a Clinical Overview); experience with client preferences (example, (1) for agency submissions, client A prefers that all data is presented individually from all phase 1 studies, not just an overall, pooled phase 1 summary; (2) when target population for a compound is an elderly population, client prefers devoting more text to adverse events that may be especially concern an elderly population). Also, interpretation of the results in the form of tables, listings, figures is a skill and an aspect which needs strong attention to every detail, hence requires the medical writing expertise. In some cases, together with template, the client also provides a model document so as to ensure that the medical writer prepares the working document in line with the model.

Any doubts which arise while preparing the draft document should be carefully handled, by initially utilizing the internal experience, best practices, lessons learnt, knowledge sharing etc. It is only then the medical writer should generate the list of queries-to-client. It is strictly not advisable to always reach out to the client for clarifications because at CRO we provide professional expert service for which the client approached us. This creates a negative impression on the expertise involved together with the quality of the service. Therefore, an internal review to improve the quality of document always plays a significant role before the client review. Always impose a pre-discussed deadline to schedule a review so as to keep work on track.

Comments from multiple client reviewers ‘within’ a single line function should be handled sensitively and thus it is better to initially agree upon, before sending the document for review, as who will provide the comments and who will act a spectator, so that the latter could be marked in CC of the email.

It is the medical writer’s job to prepare a clean-read (spell-check, grammar, formatting, accuracy of citations, cross-referencing etc. adhering to the client style guide) deliverable document before sending to the client else this can prove distracting, who in turn may not be able to focus on providing the necessary feedback on content. When this step is not ensured to the client’s satisfaction it may lead the client to infer that the content is less than satisfactory as well.

It’s also helpful to provide comment logs along with drafts. This allows the writer to communicate exactly what input they need from the client in a systematic manner. By then adding client responses to the log, this can quickly clear up any misunderstood issues, if there are any, and it ensures that the team and the client are on the same page. A good draft should be so prepared that it may need only minor changes post-review, rather than substantial revision.

By the final draft, the writer must keep track of multiple versions, consolidate comments and any feedback from the client should be integrated into the document. Before it is delivered, it should also go through a formal quality control (QC). This is where the entire content is thoroughly checked against sources for accuracy, consistency, completeness; which can be anything from an email with wording provided by the client, to the number of adverse events provided in client table, to agreed upon responses in a comment log. Documentation of the communication happened throughout the entire writing and reviewing period is highly important. As rightly said, if you don’t have proof of an information exchange, then it never really happened!

CROs have a wide spectrum of customers who all have different requirements in terms of templates, language, presentation, etc. Such a variety of customers bring diverse indications to work on, whether it be hypertension, Alzheimer’s disease, psoriasis or a vaccine. Medical writers within a CRO can therefore be exposed to a wider variety of documents (and indications) in a shorter timeframe.

In the end, clients will prefer a CRO that have medical writers who consistently produce high quality documents in the promised time frame. A quality document delivered a week late, does no good to the client. And the converse is also true – A document completed on time, but if it’s less than stellar, then the client may move their business elsewhere. Time is money, especially when a company is trying to get a product to market. With so many CROs out there, pharmaceutical companies have their pick of medical writers to work with, so the measured index of productivity is to consistently deliver quality documents in a systematic and timely fashion.