We offer a breadth of expertise and research experience, and have been involved in the design and evaluation of over one hundred Phase 1 studies, including more than 50 abuse liability studies, as well as first-in-man, pharmacokinetic, drug/alcohol interaction and proof of concept studies. We have experience in multiple therapeutic areas, such as addiction, pain, epilepsy, obesity, anxiety, depression, ADHD, and neurodegenerative disorders. Our expertise in abuse liability has led to invitations to present at meetings with FDA involvement, which have helped shape the regulatory landscape in this evolving area of research. Our services include scientific consulting in abuse liability and abuse deterrence, clinical pharmacology and early phase drug development, and regulatory strategy.
Abuse Liability and Abuse Deterrence
We provide scientific, regulatory and operational input on abuse liability assessments for new chemical entities (NCE) and abuse-deterrent formulations (ADF). We can help you at all premarket stages of program or study development, from initial planning up until the regulatory submission.
- Full study design, synopsis and protocol development capabilities.
- Extensive experience writing abuse potential clinical study reports and providing meaningful interpretation of pharmacodynamic results.
- Review of statistical analysis plans (SAP), source documents, and database requirements, to ensure that these documents are optimized to meet study goals and facilitate development of the regulatory package.
- Support with regulatory interactions, including correspondence, briefing documents, preparation for and attendance at meetings.
- Develop abuse liability evaluation programs, including gap analyses and advice on preclinical assessments.
- Assist with or fully develop the eight-factor analysis (NCE) or tier labeling analysis (ADF), for the abuse liability assessment package of the NDA/505(b)(2) submission. We also have experience with EMA abuse liability submissions.
Clinical Pharmacology and Early Phase Drug Development
We provide advanced input on Phase 1 study design and drug development programs, particularly for CNS drugs.
- Synopses or full protocols for early phase clinical pharmacology studies, including first-in-human, pharmacokinetic, drug/alcohol interaction, thorough ECG, safety, and proof-of-concept/mechanism.
- SAP, source document and database review
- Clinical study reports of all types of Phase 1 studies.
- Literature reviews, expert opinion reports (‘white papers’ or position papers)
- Development and validation of new clinical or scientific models or measures
- Development of educational (CME) or marketing materials for CNS drugs and ADFs
Contact us for more information about our services