Our consultants develop programs to assess drug efficacy, safety, tolerability, pharmacokinetics, pharmacodynamics, and dose-response from first-in-human through proof-of-concept clinical trials. We establish go/no-go decision points while ensuring the generation of comprehensive, robust data sets to achieve regulatory endorsement. Our strong emphasis on critical CMC activities ensures the timely supply of validated API and drug product for clinical and nonclinical studies. NGT provides the following Strategic and Operational services:
CASE STUDY- Leveraging Early-Stage Clinical Data, Enabling the Start of Phase 3
After completing Phase 2 clinical trials for a small molecule cardiovascular asset, a pharmaceutical company wished to advance a new salt form of the active moiety, possessing superior physiochemical properties, into Phase 3. The company hoped to leverage data from a Phase 1 PK/PD comparator study with the FDA to mitigate the need for larger Phase 2 clinical studies.
NGT subject matter experts reviewed the data in the clinical study report (CSR), researched public-domain literature, and consulted with Key Opinion Leader’s. A report was written outlining approaches that would hold up to regulatory scrutiny.
The client accepted NGT’s recommendations, commencing dialogue with the FDA, and laying the groundwork for entry into Phase 3.