CSOFT Health Sciences SVP Dr. Nimita Limaye has taken the time to answer some questions from our guest audience regarding different topics in the medical writing industry. In her first interview, she focuses on key factors that cause businesses to outsource their medical writing needs.

Jane: Hi Dr. Limaye, what do you think is the top priority while making decisions regarding the outsourcing of regulatory medical writing services?

Dr. Limaye: Jane, to me, quality is of prime importance. The generation of high-quality documents by regulatory medical writers is crucial to the success of a clinical trial and to obtaining timely regulatory approvals. Skilled medical writers bring multi-dimensional skills to the table, including rich experience in authoring different document types, strong therapeutic area expertise, a deep understanding of evolving regulatory requirements and ICH-GCP guidelines.

The ability to interpret complex data and present it in a concise and an objective manner is also very important. Regulatory documents are not just a compilation of information or a data-dump, but represent a well-thought-out strategic messaging tool.

Jane: Do soft-skills play an important role as well?

Dr. Limaye: Absolutely! The regulatory medical writer needs to have excellent project management and negotiation skills, working with conflicting demands from multiple stakeholders, including clinical teams, therapeutic area leads, biostatisticians, data management folks, regulatory leads, etc. to drive alignment. In addition, co-authoring skills are important, as there may be multiple writers working on an on outsourced document together in an outsourced partnership. Lean authoring is another important skillset that a writer should possess as firstly regulatory documents can be data intensive and generating a lean and a well-structured, yet complete document is balancing act that requires considerable finesse! Secondly, when medical writing is outsourced, the effort to ensure optimal oversight often results in a duplication of effort, defeating the entire objective of outsourcing. Hence, a lean approach, ensuring clear assignment of responsibilities and accountability is important. A patient and a level-headed approach are other important attributes, as documents undergo multiple revisions, data gets updated, the document strategy may be revised, and the formatting or template requirements may change. M&As don’t disrupt only organizations, they can turn all your medical writing standards upside down!

Jane: Cool. So, which is the next most important priority driving outsourcing decisions?

Dr. Limaye: Oh well, I would say it is alignment between the organizations. This includes operational, business model and cultural alignment. Let’s speak 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.

About CSOFT

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.