Medical Affairs & Scientific Strategy

Baker Tilly’s medical affairs specialists can work with you and your medical teams as well as brand leadership to develop a comprehensive medical strategy that is aligned to your brand objectives, including planning for evidence generation, engaging with key opinion leaders (KOLs) and aligning your medical affairs team with your commercial function.

Offering highlights

• Comprehensive plan that accounts for the scientific and strategic needs of a brand
• Detailed, actionable and measurable outcomes that are grounded in scientific expertise and medical literature

Baker Tilly can help evaluate your evidence landscape across your therapeutic area to identify gaps, weaknesses, and opportunities related to generating new clinical and economic evidence to support your brand and portfolio objectives.

Offering highlights

• Landscape and gap analysis
• Stakeholder priorities and alignments identification
• Clinical and economic evidence assessments

Baker Tilly can conduct an in-depth assessment of your organization’s clinical, medical, and scientific processes to identify gaps and weaknesses in the governance environment, including policies, procedures, training, and change management processes. We also work with key stakeholders to secure coverage of medical and scientific risk areas, including:

• Healthcare provider (HCP) interactions
• Promotional materials
• Investigator-initiated and company-sponsored research
• Medical information requests
• Evidence-generation planning
• Medical education grants

Offering highlights

• Key risk areas impacting medical and science
• Governance risk assessments
• Policies, procedures and training (i.e., remediation services)

Baker Tilly understands that life sciences companies can succeed when they have taken steps to ensure studies are well designed, executed and published. We understand because we have also been there. From concept to protocol to generating conclusions, Baker Tilly can collaborate with you each step of the way to strategically help you through the study design and data analysis process.

Offering highlights

• Study design development and methods choice
• Protocol development/IRB submission
• Study management (including recruitment and retention support)
• Data analysis planning and execution

Baker Tilly provides senior clinical and scientific advisory experience to fulfill the requirements of vacant and under-resourced scientific leadership roles, including clinical development, medical affairs, health economics and outcomes research (HEOR), chief medical officers (CMOs) and more.

Offering highlights

• Scientific and medical strategies and services on an as-needed basis
• Comprehensive senior support for needs across therapeutic areas and research applications
• Turnkey solution – flexible and scalable with broad medical and scientific scope that meets client needs at each stage of development

Baker Tilly can evaluate your organization’s scientific communication platform and assets to identify and optimize the scientific narrative and value proposition, develop assets, plan for publication, and develop tools for managing scientific references and claims.

Offering highlights

• Medical and scientific narrative and value prop
• Dossier development
• Medical claims and reference support
• Scientific and medical content development

Baker Tilly understands that your field team is a key pillar of your business as they navigate coordinating with other field needs with promotional functions. We also understand that field representatives have unique key performance indicators (KPIs) and goals that vary across departments and positions. At Baker Tilly, we can work with your field teams to define the importance of strategic account management while clearly identifying guardrails to separate promotional and nonpromotional objectives.

Offering highlights

• Field team training
• Medical information request process
• Strategic account planning templates and exercises
• Mock joint medical/nonmedical HCP interactions

It is critical for life sciences companies to build relationships with thought leaders who can influence the opinions and behaviors of HCPs and patients. However, it can often be hard to find KOLs and build relationships prior to an engagement. Furthermore, for each instance that you may need a thought leader, you should have a KOL identified, picked, evaluated and compliance implications considered.

At Baker Tilly, our proprietary technology, kolNOW™ , can help with the KOL identification, evaluation and selection process. With access to more than 10 million pre-tiered KOLs around the world, our team and technology can meet your KOL engagement goals as well as compliance requirements.

Offering highlights

• Identify KOLs who can help your company achieve your strategic goals
• Create personalized engagement plans for KOLs, including one-on-one meetings, advisory boards, speaker engagements, and medical grants or sponsorships
• Measure the impact of KOL engagement metrics, such as the number of speaking engagements, publications and social media interactions