Global Drug Development Experts
At Global Drug Development Experts, LLC we specialize in partnering with Pharmaceutical, Biotechnology and Medical Device firms to Design & Execute Clinical Trials, integrate Rapid Patient Enrollment Solutions into clinical trials, and design Rescue Clinical Trials/Address Delayed FDA Submissions. We are a team of experienced professionals with a breadth of clinical trial knowledge derived from decades in senior executive level positions at large Pharmaceutical Companies and CROs. Each member of our team is first and foremost a "problem-solver", and we draw upon an extensive tool-kit of solutions to rapidly address even the most difficult challenges faced during the conduct of clinical trials, and the submission of documentation to regulatory bodies such as the FDA.
Our team has brought many drugs and devices to the U.S. market over the past 20 years by designing clinical trials that can be rapidly executed around the world. Our areas of expertise:
- Integrating Rapid Patient Enrollment Solutions
- Designing cost-effective trials for new indications
- Rescuing Clinical Trials
- Addressing Delayed FDA Submissions
- CRO assessment and management for small Biotech Companies
- Due diligence and evaluation services for Companies providing Venture Capital Funding or Investment
GDD Experts provides clinical expertise for the design and implementation of clinical trials with particular attention to geographies outside the United States such as: India, Central and South America, Eastern Europe and Russia. We have over 20 years of experience from IND submission to FDA approval.