Supporting Phases 1 – 3, our suite of clinical and medical services include strategic planning and study design, study implementation, and data analysis.
Strategic Planning & Study Design
Your clinical development plan needs to reflect your goals and objectives. What labeling claims do you need to be competitive? What would regulators likely think about your product? Would your product be attractive for acquisition if it met certain milestones? What resources and investments will be required to achieve those goals? Let us help you answer those questions and more so you can be sure to design a study that will address the needs of your stakeholders, whether they are internal, regulators, venture capitalists, or commercial partners.
Our strategic planning and study design services include:
- Literature reviews
- Regulatory guidance
- Protocol development
- Case report form development
- Statistical analysis plans
- FDA meeting presentations and representation
- Sponsor advisory board presentations, representation, and coordination
As any phase or study is completed, we review and update clinical development plans based on the results and regulatory guidance to ensure your development plan remains optimal.
Our structure allows the flexibility to customize implementation, providing appropriate technical and human resources as required. We oversee all aspects of study implementation and operations, including:
- IRB/EC approval
- Site selection and monitoring
- Investigator meetings
- Subject recruitment and informed consent
- Medical monitoring
- Safety surveillance and pharmacovigilance
- Data management
- Central laboratory performance
- Regulatory reports
- Quality assurance
- Project management
Analysis & Reporting
Our biostatistics team provides analysis and if needed, can design and conduct ad hoc analyses to ensure that any signal of efficacy is accounted for and to ensure that any safety signal is identified as early as possible.
After your data have been analyzed, our biostatisticians, clinical research scientists, and medical reviewer work together with our medical writers to ensure your clinical study reports are accurate, complete, and what regulatory authorities expect.