Leveraging External Expertise for Core Functions
The medical affairs function has traditionally been handled in-house by pharmaceutical companies. However, outsourcing certain medical affairs activities is becoming increasingly popular as drugs progress through their lifecycle. By leveraging qualified external partners, companies can gain scalable medical and regulatory expertise on an as-needed basis.
Outsourcing helps ensure the availability of therapeutically knowledgeable medical science liaisons (MSLs) and regulatory specialists during key phases such as launch preparation, product approval, and post-marketing surveillance. External experts can provide the necessary human resources without companies needing to carry large in-house staffs year-round. This delivers better focus of internal resources on strategic priorities.
Harnessing Therapeutic Knowledge
When bringing a new medicine to market, companies depend on MSLs to effectively engage with healthcare professionals (HCPs) and build understanding of the product and its clinical data. Medical Affairs Outsourcing allows companies to ramp up their MSL capability temporarily using experienced contractors in the therapeutic area. These MSLs hit the ground running with deep disease knowledge and expertise presenting clinical evidence to HCPs.
For in-demand therapeutic specialties, it may be difficult for companies to hire and retain a sufficient number of full-time MSLs. Partnering with medical communications agencies ensures availability of MSLs who are experts in rare diseases, for example. This expertise is tapped selectively as product approvals occur or new data emerges for dissemination to the medical community.
Managing Regulatory Commitments
New drug applications and ongoing post-approval commitments like risk evaluation and mitigation strategies (REMS) require strict regulatory compliance. Leveraging specialized regulatory outsourcing providers helps companies supplement internal resources to effectively complete required tasks.
For instance, many REMS involve surveying or educating HCPs through various communication channels. Outsourcing vendors have experience executing large-scale REMS deliverables on schedule using technology-enabled project management approaches. This lightens the resource burden on internal medical affairs staff.
Clinical Trial Program Support
As medicines advance through clinical development, outsourced partners can aid internal medical teams. For instance, when conducting a late-phase study in a new geographical region, outsourcing provides additional clinical trial monitoring capacity and therapeutically skilled staff.
Medical communications agencies also expertise in designing and implementing investigator meetings and interactive advisory boards. These inform key opinion leaders and elicit valuable perspectives to refine clinical programs. Such meetings require coordination across multiple therapeutic and geographical areas of expertise―making outsourcing an efficient option.
Outsourcing thus enables companies to stay focused on core strategic work while tapping external expertise on demand. This optimizes responsiveness to new developments or requirements throughout a product's lifecycle via a variable cost model. Leveraging qualified partners delivers the medical and regulatory know-how needed during priority activities.
Get More Insights on Medical Affairs Outsourcing
Get this Report in Japanese Language- メディカル・アフェアーズ・アウトソーシング
Get this Report in Korean Language –의료 업무 아웃소싱
About Author-
Vaagisha brings over three years of expertise as a content editor in the market research domain. Originally a creative writer, she discovered her passion for editing, combining her flair for writing with a meticulous eye for detail. Her ability to craft and refine compelling content makes her an invaluable asset in delivering polished and engaging write-ups.
(LinkedIn: https://www.linkedin.com/in/vaagisha-singh-8080b91)
