Therapeutics Inc.’s development
team can work with you to formulate a plan to guide your drug,
biologic or medical device through the regulatory pathways to
approval. Our staff has decades of experience in providing clinical
and regulatory services to numerous pharmaceutical, medical device
and biotechnology companies. Therapeutics’ drug development
staff works closely with the clinical operations group as a dedicated
team, focused on completing your project according to your specifications.
Services offered by
Therapeutics, Inc. include:
Development Planning
- Develop roadmap of key activities and deliverables to support registration and market success.
- Integrate CMC, non-clinical and clinical development to maximize efficiency, reduce costs, and increase development velocity.
- Manage project from concept to market.
- Manage manufacturing site selection, qualification and oversee technology transfer.
Non-clinical Development
- Design and manage pharmacology and toxicology programs.
- Develop and manage formulation and analytical chemistry; define and manage formulation development.
- Develop CMC sections for regulatory submissions.
- Review the development of analytical, stability and formulation
programs to support regulatory filings.
- Perform risk analysis for CMC issues related to NCEs.
Clinical Development
- Design "General Investigational Plans".
- Develop clinical protocols, CRFs and consent forms
for Phase I through Phase IV studies.
- Develop CRF guidelines and investigator brochures.
- Author CSRs, ISSs and ISEs.
- Perform medical monitoring.
- Provide data management oversight.
- Select, contract and manage qualified clinical investigators.
- Provide investigator meeting services.
- Prepare and submit documentation to central IRBs.
Regulatory Affairs
- Provide strategic regulatory planning and implementation during all phases of development.
- Monitor changes in regulations related to drug/device development.
- Prepare, review, file and maintain regulatory submissions
(e.g., INDs, NDAs, BLAs, CTDs, IDEs, PMAs, 510(k)s, etc.).
- Assist clients with preparation for agency audits/inspections.
- Represent clients at FDA meetings.
Biostatistics
- Review clinical protocols for statistical content.
- Calculate sample sizes for clinical studies.
- Generate randomization schedules.
- Develop statistical analysis plans.
- Perform statistical analyses.
- Assist with data interpretation and report writing.
