CLINICAL AND REGULATORY AFFAIRS
Sponsors need an extra set of hands for their clinical development plans and regulatory discussions while they are constraining their cash burn. CRS advocates preparedness and openness to eliminate hidden surprises and unnecessarily repeating work later.
We’ve written clinical protocols and investigator brochures, conducted literature reviews and market assessments, and prepared regulatory pre-IND or Q-sub documentation to take to the regulators for those early discussions.
Highlights of this work include a first-in-class medical device for Alzheimer’s disease, breakthrough designations, regenerative medicine biologic products for diabetes, digital therapeutics for patient monitoring and mental health, and several pharmaceutical-grade cannabinoids. All of these require intensive study of the regulations for pre-clinical and clinical requirements in preparation for discussion with regulatory bodies.
Other innovations we bring to the forefront are decentralized and virtual approaches to research, real-world evidence (RWE), Bayesian (adaptive) design, master protocols, parallel EMA/FDA and matching technological innovation to reduce costs of research.
A few specifics include:
- Clinical Development Plans
- Project Management
- Regulatory Strategy
- Rescue Trials
- F2F Negotiations and Written Communications with the FDA, Health Canada, and Competent Authorities (de Novo, 510k, IDE, HDE, IND)
- Emergency Use
- Sponsor-Representative IND Regulatory Agent
- Trial Planning, Efficiency, and Operations
- Patient Recruitment and Enrollment Rates
- Patient Input
- Realistic Costs and Timetable Projections
- Resourcing Decisions and Recruitment
- Team Training on Regulatory and ICH-GCP topics
Mobilizing for COVID-19
When COVID-19 struck and our client projects were delayed or suspended, we mobilized toward the problem and quickly adjusted to the new reality by acting upon new opportunities to fight the virus. We aided in Emergency Use Authorization submissions and regulatory discussions pro bono, shifted our teams to COVID-19-related clinical trial support and remote monitoring, presented in webinars on the impact of the virus, and agreed to join the RADx army of experts to accelerate diagnostics innovation in record time.
For the tens of thousands in life sciences who have lost their jobs, we helped a portion reinvent themselves and connect to consulting work or unposted opportunities. We are at our best by giving back to help the economy recover.
WE’RE READY TO BE YOUR EXTRA SET OF HANDS … AND STRATEGISTS
Contact us today for a free phone consultation.