At FHA, there’s only one thing we ever settle for. Your success.
Proven both valuable and effective through a comprehensive list of project successes, FHA provides clinical research design and strategy, data analytics, medical/safety monitoring and oversight services.
Through our extensive experience and teams of highly-trained medical professionals, we develop effective strategies and execute high-quality programs, which generates the highest quality data to meet your overall scientific needs.
The CMO plays a vitally important role in both pharmaceutical and biotechnology companies. It is a role that can vary greatly in both scope and responsibilities. In emerging organizations, the role may be one that is more clinically focused. While in larger, more established companies, the areas of responsibility may be directed towards policy and medical affairs. In the case of either and all of those in between, our former CMO’s are keenly aware of what keeps people “up at night” and channel their expertise, experience and knowledge into providing the highest levels of performance, trust and diligence. Their goal in partnering with you is success, satisfaction and peace of mind for your organization.
We leverage our knowledge and experience in offering the following services:
- Serving as interim CMO during periods of company transition or for “virtual” companies
- Designing clinical programs and implement medical oversight aligned with ICH E6 and FDA Risk-Based Monitoring
- Designing CMO performance ‘dashboard’ to visualize and track elements from CMO areas of responsibility
- Establishing global and local medical governance structures
- Performing medical due diligence at the product or enterprise level
To ensure robust and comprehensive medical oversight of clinical trials activity, FHA employs a proprietary five-step approach:
- Understanding the program and establishing the monitoring goals
- Designing the most effective approach, timing and documentation strategy
- Determining all data needs and design data outputs
- Analyzing data, reaching conclusions, formulating recommendations
- Documenting, communicating and refining the approach as required
The FHA team has significant expertise and experience with clinical trials and safety governance activities. Among the many services and activities is governance supporting dose escalation decisions in early-stage trials, performing overall safety reviews of clinical and/or post-marketing data, and all other situations where a governance approach is required.
We perform the following services for Safety Advisory Committees, Data Safety Monitoring Boards, Dose Escalation Committees and other Scientific Advisory Boards:
- Governance committee charter authoring and development
- Direct membership, including leadership, of safety and clinical governance bodies
- Appointing an advisor from our extensive network onto a safety governance body