Implementing a robust Medical Affairs strategy that aligns to your business strategy and the healthcare compliance guideline enhances safe and effective adoption of your medical products.
Generation of various levels of evidence to demonstrate clinical and economic outcome of your innovative products to diverse stake holders spans pre- and post-market studies, sponsored and investigator initiated clinical trials, real world evidence.
Convening Advisory Panels of field experts within the guidelines of healthcare compliance to receive guidance on areas such as design, functionality, and adoption of your technologies, educational approach, plan for evidence generation, and producing consensus documents.
Identifying, engaging and building lasting relationships with top tier Key Opinion Leaders, up and comers and advocates, collaborating on strategic initiatives.
Establishing a clinical development plan with clinical trial designs that best address key clinical outcomes for the right populations with high levels of integrity and efficiency.
Strategy for publication and communication of clinical and economic evidence to the right audience at the right place. This includes careful publication strategy and a plan for communicating evidence at the right venues.
Review and drafting of Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, and Post Market Clinical Follow Up Plans to demonstrate compliance with EU MDR and conformity with the MDD regulations.
Technology assessment and evaluation of business plan for merit, safety, clinical and medical perspective to help answer investors' interests.
Interface with the clinical investigators, addressing issues and questions that may arise during clinical trials, review of safety events and signal detection.
Providing leadership to your medical and clinical teams by proven industry leader.
Devising strategy and plan for medical education, drafting curriculum and educational material.
This also includes a strategy for CME programs.
Review and draft of adverse event narratives, PSURs. identification of safety signals.
Setting up MSL strategy and programs, and providing hands-on leadership to your MSL team