Exponent’s Health Sciences professionals bring the skills and experience necessary to assist you in the design and completion of your clinical development programs. Our drug development staff has proven expertise in bringing new drugs and drug combinations to market. Exponent scientists help clients advance their products from the bench to human proof of concept clinical trials while containing costs, reducing time, and minimizing risks. Working with CRO’s we develop a detailed strategic plan along with a budget analysis, so your projects stay on track and your investors are well-informed. For every project, we identify critical issues to minimize delays and define the best strategic route to market.
Exponent scientists and clinicians can assist pharmaceutical and biotechnology companies in meeting the growing demands required for both US and worldwide product approvals. The most common services we provide are listed below. Please contact one of our senior drug development consultants to discuss your specific needs.
Clinical Development Services
- 505(b)1, 505(b)2, 505(j) submissions
- Small molecules and biologics
- Clinical development strategy for initial indications and label extensions
- Phase I-IV protocol development - including imaging studies for inhalation products
- Initial dose setting based on preclinical data, indication(s) and delivery system
- Preparation of investigator brochures (IB) and annual IND safety reports
- Preparation of informed consent documents
- Pharmacokinetic, drug-drug interaction and bioequivalence trials
- Clinical Advisory Board selection and moderation
- CRO selection and management
- IRB selection and management Data management
- Drug safety monitoring management
- Statistical analysis
- Clinical study report writing
- Preparation for and representation at FDA/regulatory authority meetings
- Interactions with FDA and other regulatory authorities
- Paper and/or eCTD preparation of regulatory submissions (IND/NDA, CTA/MAA, BLA, ANDA etc)
- Clinical trial submissions and updates to ClinTrials.gov