Medical Affairs Field Teams
Medical Affairs Field Teams are critical to establish external relationships with scientific leaders and prescribers for scientific exchange and engagement. Insights gleaned from these relationships inform R&D trial planning and promote understanding and awareness around new and emerging product scientific data in a complex and rapidly changing environment.
Building a medical team with a focused strategy can accelerate product development and will ultimately result in availability of new and better therapies to patients in need.
Golgi-ADVISE™ has extensive experience in the following medical affairs activities:
Initial Team Build-out
Medical Science Liaison (MSL) Recruitment Strategies
Field Strategy and Objectives
Performance Metrics
Team-Building and Retention of Staff
Congress Planning
New Product or Scientific Data Dissemination
Clinical Trial Site Identification and Personalized Site Engagement
Medical Support of Product Launches
Investigator-Sponsored Research
Investigator-sponsored research programs or Investigator-initiated trials (IITs) generate valuable product information and expand the benefit/risk profile of therapies in clinical development in specific populations that may not be part of the company-sponsored clinical research programs.
Over the past decade these collaborative programs have been essential to fill the gaps of knowledge within the clinical development program.
Golgi-ADVISE™ can support your IIT program planning in the following areas:
Prioritization of IIT Program Goals
Development of Areas of Interest for Proposals
Dissemination and Discussion of Areas of Interest (AOI) to Investigator Community
Confirmation of Investigator Qualifications for conduct of independent research
Proposal Submission Guidelines
Proposal Review Committees and Review Guidelines
Communication of Funding Decision
Budget and Contract Execution and Grant Payment Management
Overall Oversight of IIT Program
Scientific Advisory Activities
Formal Engagement with Key Scientific Leaders via Medical Advisory Boards, Steering Committee Meetings, Scientific Symposia, Round-table discussions or Investigator Meetings are efficient and effective strategies for soliciting essential input from the scientific community.
Well-planned and executed advisory meetings save time, expense and effort related to clinical trial start-up, to understand and address issues leading to stalled trial recruitment and to gain valuable input to guide R&D activities.
Golgi-ADVISE™ has broad experience in the following advisory meeting activities:
Develop Overall Meeting Objectives and Key Scientific Questions
Identification and Outreach to Thought Leader Participants
Slide and Meeting Content Development
Meeting Conduct including serving as Meeting Chair (if desired).
Executive Summaries with Key Take-aways
Full Meeting Report and Post Meeting Debrief
Allied Health Advisory Meetings including community-based physicians, advanced practice providers (PAs, FNPs), pharmacists and nurses
Advocacy Group Meetings
Clinical Development Programs
Clinical Trial Enrollment Challenges are a common issue in the pharmaceutical and biotech industry with an estimate of up to 80% of trials failing to meet their planned enrollment timelines.
There are many reasons for delays ranging from trial design, inability to identify trial sites with the appropriate patient population, changing landscape of care, lack of patient awareness about trials and competitive trial threats.
Golgi-ADVISE™ can help in the following clinical development areas:
Clinical Trial Design and Feasibility Review
Protocol Development - Phase 1 through Phase 4
Basket and Umbrella Trial Design
Biomarker and Other Trial Enrichment Strategies
Regulatory - Accelerated Review and ORBIS Review Strategies
Incorporation of Real-World Evidence (RWE) and Real-World Data (RWD) and Patient-Reported Outcomes (PRO)
Trial Diversity Planning
External or Synthetic Control Arms
Site Identification and Selection Strategies
Vendor Outsourcing Strategies