Company insight
Most pharmaceutical companies give only ten working days and limited information to prepare their proposals. Yet, the average time to write a single RFP response is up to 39 minutes per question, not including time to assess the RFP, format responses, collate supporting material and so on. When bidders have too little time, they tend to provide less information and standardised responses, giving you less insight into the individuality of the provider. Give bidders adequate time to prepare their proposals – including time to ask all their questions, and digest all the answers to their questions – and there will be more meaningful information on which to make a decision.
Stage three: Managing the services provided Outsourced service providers in general, and medical writers in particular, should be “part of the family” and not just “one of the servants”. It is very difficult for a writer to distil the right messages if companies don’t integrate them into the clinical teams. If medical writers are not invited to strategic meetings in which content is discussed, they will lack important details on background, decisions, and strategy.
reduces the time for assessors to review the documents. Communicating effectively is about capturing the many nuances behind an idea. By understanding the rationale behind the thoughts, a writer can suggest how best to build the information into a coherent story that says exactly what it needs to. Managing medical writing services should ensure the writer is an empowered member of the authoring team. This requires a company culture that educates internal teams to embrace their external members, and makes sure: ■The writer has all of the relevant information needed as soon as it becomes available.
■There are regular team meetings to discuss new ideas and changes in strategy.
■Team meetings include all contractors providing services relevant to the authoring process. This way everyone is informed about all issues and decisions are made as a team.
■Internal colleagues listen to and use the expertise of their external providers. Writers have good suggestions for planning, coordinating and performing the writing activities and these
“Outsourced service providers in general, and medical writers in particular, should be “part of the family” and not just “one of the servants”. It is very difficult for a writer to distil the right messages if companies don’t integrate them into the clinical teams.”
Stop and think about what a medical writer provides. If you think they just “get everything down on paper” and make sure there are no spelling mistakes, you are missing out on what they can offer. An experienced medical writer brings a wealth of knowledge about how to structure thought, present information effectively, and guide you through the writing and review process. A well written document communicates without the reader having to work at it, which ultimately
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help teams optimise getting the job done. Listen to them and take their advice. That is what you are paying them for.
Stage four: Evaluating performance at the end of the project
It is important to avoid an outsourcing model designed only to find the cheapest bidder on a document-by- document basis. If a writer or group of writers is good, it is in everyone’s interest to keep them for the
long run. With their knowledge of previous documents, they can ensure that subsequent documents are consistent with these, and they understand the dynamics of the team they are working with.
Evaluating performance at the end of projects is, therefore, important to decide whether to continue working with the same writing company. Once a project is complete, take the time to meet with the key clinical team members and the medical writer to share and discuss everyone’s thoughts on how well the collaboration worked. Prepare a list of those things that both sides felt worked well and those things that need improvement. Then discuss these and work together to define a solution.
Listen to the feedback from the writer about areas that may need improvement internally. Many writing projects spiral out of control because the team is unable to give the writer clear instructions. This may result from divided opinions within the company. To save face, internal groups often put the blame on external providers rather than acknowledging that the problem was a result of an internal communication breakdown. Working together with the medical writing provider to identify and resolve problems is worth the effort and an important part of optimising the overall process of outsourcing medical writing.
Conclusion
Successfully outsourcing medical writing depends on selecting medical writers who not only understand the needs of each document but are also proficient coordinators and who will challenge clinical teams to present a clear, well-argued story.
It is important to work together, communicate frequently and integrate the writers onto the clinical team throughout the writing process, and to share good and bad experiences from working together to develop and maintain a relationship that is mutually beneficial. ●
References available upon request
www.trilogywriting.com
Medical Device Developments /
www.nsmedicaldevices.com
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