Medical Affairs & Scientific Strategy
Medical Affairs & Scientific Strategy
Baker Tilly’s medical affairs services helps life sciences companies balance clinical communications with novel evidence generation through landscape and gap analysis, fractional medical and scientific management, field team excellence and KOL engagement strategies.
Guiding life sciences companies through their medical affairs journey
As the role of medical affairs continues to be acknowledged for its function as a primary strategic organizational pillar, life sciences companies must empower medical affairs to bridge the scientific gap by generating and communicating clinical knowledge to stakeholders and patients. These organizations must also develop strategies that align medical affairs activities with core business goals that are supported by outcomes research and real-world evidence (RWE) for their products or therapeutics to be successful in the market.
At Baker Tilly, our team of life sciences industry specialists have foresight into the future state of medical affairs and provide the strategic lens that medical device and pharmaceutical companies need to achieve success now, and tomorrow.
Our team is made up of professionals including epidemiologists and other scientists who have conducted research across a wide range of settings and disease states. We also operate across therapeutic areas and patient populations to identify and develop a medical and scientific strategy for your brand that blends scientific and operational objectives to help you and your organization achieve your medical affairs goals.
With our years of real-world and practical experience, we are able to provide clarity and timely advice that addresses your company’s specific and unique challenges. With this burden of navigating nuanced scenarios taken off your plate, your team can focus its time and energy on important transitions and your organization’s journey of accomplishing its strategic goals.
Medical affairs solutions
Baker Tilly’s team of specialized professionals are prepared to support you and your company with a wide range of medical affairs solutions, including establishing medical launch teams, developing scientific communication platforms and defining your evidence-generation strategies, all while managing risk and developing guardrails to support your field teams.
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
Featured insights
Medical affairs and the value of epidemiology expertise
Download Baker Tilly’s and the Accreditation Council for Medical Affairs’ (ACMA) informative whitepaper to learn about the changing role of the medical affairs function within life sciences companies and the value of epidemiological expertise.
Diagnostics company strengthens medical affairs function through governance assessment
Multinational diagnostics company collaborates with Baker Tilly to conduct a governance analysis to identify key gaps in policies, procedures and governance documents within its medical affairs function.
MedTech company revises messaging of existing product to gain additional payer coverage
Learn how Baker Tilly helped a global medical technology company revise the messaging of its existing spinal stimulation implant to help gain additional payer coverage and expand patient access.
MedTech company launches digital health platform with help of effective clinical study design
Learn how Baker Tilly helped a large MedTech organization design and run clinical studies in order to successfully launch a new digital health platform.