CSOFT Health Sciences SVP Dr. Nimita Limaye joins us once again to continue her interview on Key Factors Driving Medical Writing Outsourcing Strategy. This time, she focuses on the importance of alignment in terms of business operations, business models and cultural alignment.

Jane: Hi Dr. Limaye, continuing on our earlier conversation, you had mentioned that the most important priority driving outsourcing decisions was alignment and you had mentioned three main areas of alignment, including operational, business model and cultural alignment. Let us discuss these in more detail today. So, can you elaborate upon what you mean by operational alignment?

Dr. Limaye: Jane, when I am referring to operational alignment, I am referring to things such as SOPs, templates, style guides, trainings, organizational structures and job titles. Medical Writing RFPs do look for alignment in terms of relevant therapeutic area expertise and functional expertise. Sponsors many a time want outsourced teams to work on their SOPs and templates – not all CROs are flexible with that. What adds to the complexity, is when the CRO is working with different teams at the sponsors’ end. More often than not, those different teams, especially if they are from different locations or different therapeutic areas, have different expectations regarding document formats or the way data should be presented. This becomes challenging for a CRO’s team that has just learnt and adapted to the expectations of one team at the sponsor’s end, only to realize that working with the other team is another ball game altogether. An additional learning curve comes at a cost, which is usually, not factored in by the sponsor or the CRO. Dissonance can also create ripples in a relationship, if not managed in a timely manner.

Jane: Why do job titles matter?

Dr. Limaye: Well, if you have an offshore partnership, in a country where there is a large population of aspiring young medical writers and there are multiple opportunities available, a key retention strategy may involve offering quick career growth. The challenges however arise, for example, when the sponsor and the CRO both have similar job titles such a Lead Medical Writer, but in one case, it corresponds to five years of experience, whereas in the other, it corresponds to 15! This does occasionally tend to create some dissonance…

Jane: What about business models?

Dr. Limaye: Pharmas, biotechs or medical device companies have their own outsourcing models. Some prefer to use in-sourced writers (those which are on the service provider’s rolls, but function in the same manner as employees and work in close alignment with the internal teams, usually at the sponsor’s site). Others prefer a model of two or three key CRO partners, supported by a flexible pool of freelancers, while many large players go through a cycle of decentralization (working with multiple vendors), followed by consolidation (narrowing down to a few players) and this cycle repeats. Some may prefer dedicated teams working for them (an FTE model – an extended staffing model, working out of the CRO’s office), while others may prefer an FSP model (a Functional Service Provider model – with dedicated teams allocated to different functions). Deliverable based pricing is another desired option, where the sponsor pays a fixed price for a particular medical writing deliverable. Unlike the other models, relatively less oversight is required from the sponsor’s end for this model and may be considered to be a next step in a partnership, once confidence in capabilities and trust have been established.

Jane: Interesting. So, can you elaborate a bit upon the importance of cultural alignment?

Dr. Limaye: I think cultural alignment is of great importance between organizations. It is not necessarily about geos. It is more about the value systems, the ethos, the work ethics, the leadership, the principles that lead the business practices and the value for people. Let’s chat more the next time!

About CSOFT Health Sciences

CSOFT Health Sciences provides end-to-end medical translations for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.


CSOFT International is a leading provider of cross-border communications for enterprises seeking growth in global markets. Our expertise in localization, documentation, and branding encompasses a full range of end-to-end content and consulting services that we deliver in over 250 languages. With a focus in health sciences and smart technology, we work closely with our clients to deliver precision solutions to the challenges of engaging markets, consumers, and regulatory environments worldwide.