Life Sciences Consulting
Life Sciences Consulting
Life science companies, law firms, and regulatory agencies around the globe turn to CRA's life sciences consultants when they need clarity and solutions to the industry’s most complex issues. Clients value our deep industry knowledge, rigorous analytic techniques, and decades of hands-on experience spanning thousands of successful engagements.
CRA delivers innovative, winning strategies that set our clients apart from their peers. Clients partner with us when they want to achieve optimum direction and performance across key aspects of their business, including innovation, commercial success, organization, and reputation. We ensure they make the right decision, implement it the right way, and secure buy-in from key stakeholders.
- Portfolio design and positioning
- Competitive simulation
- Lifecycle management strategy
- R&D strategy and optimization
- Rare disease
- Organizational performance
- Organizational effectiveness
- Lifecycle management strategy
Centers of excellence
Advanced life sciences analytics refined by decades of innovation.
- Longitudinal patient journey
- Opportunity assessment
- Patient finding / imputation
- Dynamic simulation
- Physician segmentation
- ROI / promotional response
- Payer / access analysis
Market research that leverages best-in-class methodologies.
- Global research feasibility
- Product profile development
- Value proposition messaging
- Discussion guide design
- Survey development
Policy analysis backed by independence, rigor, and experience.
- Health technology assessment
- Competitive tendering
- Pricing policies
- Healthcare financing
- International trade agreements
- Evolution of regulatory trends
Competitive strategy – A leading pharma company was concerned about the impact of biosimilars in its key therapeutic categories. CRA coordinated the development and implementation of risk mitigation strategies across the client’s teams and that were subsequently integrated into brand plans.
Market access strategy – A top biotech firm was developing a global market access approach for a new therapy in an orphan disease with commoditized first-generation options. CRA conducted simulation workshops to gauge likely competitive response, and helped the client customize its strategy across key geographies.
Stakeholder engagement – Support for the UK affiliate of a top ten pharma company in a series of HTAs led to aligned and strategic engagement of internal and external influencers. This contributed to positive reimbursement decisions by NICE to ensure access to innovative new medicines.
CRA’s policy team provides analysis and insights into issues affecting the life sciences industry. We work across global, regional and national policy areas to assess and make recommendations relating to current situations and the potential impacts of proposed policy changes, in support of clients’ strategic priorities.
CRA has a reputation for independence and rigour, benefiting from long standing relationships with most leading pharma organisations as well as national governments and the European Commission and industry associations such as IFPMA, EFPIA, and PhRMA. Our specialist team has provided unique policy oversight for the past 15 years, working closely with our strategy consultants to support clients in achieving their wider corporate objectives. We deliver high quality, robust analysis but in a compelling fashion that is accessible to the target audience, whomever it may be.
Clients come to CRA’s policy team when they want to:
- Evaluate the impact of regulation and how clients can optimise their position accordingly
- Anticipating future changes in the policy environment and the business implications associated with them
- Develop policy positioning - assessing the cost and benefits of different policy options
- Support government affairs functions in managing and coordinating global policy processes in alignment with commercial priorities of the business
- Influence the macro policy environment at global, regional, and national level through robust evidence development
Specialist policy capabilities
Policy analysis – A global pharma company sought insight into the policy implications of variations in access to Multiple Sclerosis treatments across Europe. CRA’s analysis and report has helped the company build its argumentation to policy makers around barriers to effective MS treatment.
HTA impact analysis – EFPIA & PhRMA asked CRA to describe how HTA systems are evolving and their impact on access to medicines in a range of markets. The study demonstrated that HTAs are increasingly delivered in a more timely fashion but are not enabling earlier access to innovative medicines.
Reimbursement policy – CRA reviewed reimbursement of orphan medicines across Europe for a pharma company supplying therapies in this sector. A toolkit on reimbursement practices at national, regional and local levels, set out best and worst practices and their consequences, to support argumentation with payers.
CRA’s life sciences litigation support is grounded in a comprehensive understanding of pharmaceutical, biotechnology, medical device, and diagnostic markets. For more than 30 years, our experts have consulted with major life science companies, law firms, and regulatory agencies around the globe, providing the industry experience and analytical expertise needed to solve their most challenging strategic problems and resolve their most contentious disputes.
CRA has a reputation for delivering rigorous analysis and expert testimony that meets the highest standards. Our witnesses are respected for their professional excellence and effectiveness in highly demanding life sciences cases. Our team members have extensive business consulting and litigation experience in the life sciences industries. The academic backgrounds of our consultants are complemented by results-focused, practical experience. This combination allows CRA to apply effective expert testimony and non-testifying expertise to our clients’ most important problems.
Regulatory agency proceedings
- Antitrust, including reverse payments and delayed generic entry
- Class certification
- Commercially reasonable efforts
- Damages assessment
- Economic fraud
- Government investigations
- Intellectual property disputes and valuations
- International arbitrations
- Off-label marketing and product liability
- Pricing, reimbursement, and distribution
- Transfer pricing policy
- Labor and employment
A global pharma company abandoned a product launch following unfavorable clinical trial results. When their stock price fell, they were sued for allegedly concealing information. The court accepted our analysis/conclusion that information concealment was an unlikely reason for the price change.
In a matter involving an antitrust counterclaim, a generic pharmaceutical manufacturer alleged that a blockbuster brand manufacturer attempted to monopolize the market and delay entry of the generic product. A CRA expert analyzed market definition, competitive effects, and lost profits damages estimates. The matter settled favorably for our client shortly before trial.