Services

Early Phase and Development Support

Specialist support for early stage clinical trials and development clinical pharmacology

At GRS, we know that Early Phase and Development Support (EPDS) studies are not the same as those in later Phase II and III studies. GRS provides a specialized team capable of working at high speed while retaining quality under company SOPs and processes, but in a fraction of the time allowed in later stage studies. All standard metrics are reduced for EPDS studies, accomplished through efficiencies learned over many years of working in EPDS. Established relationships with Clinical Pharmacology Units (CPUs) and external vendors allow for swift contracting while the use of standards within GRS leads to rapid project plan generation, investigator file set-up and, most importantly, CRF design and database set-up. Our staff has a vast array of experience that includes:

• More than 400 EPDS studies
• More than 100 compound and vaccine classes ultimately targeting over 80 indications
• Enrollment which ranges from large development support studies (1,081 subjects at 23 sites globally) to small radio-labeled studies (6 subjects at a single site)
• Studies examining pharmacokinetics (PK), pharmacodynamics (PD), special populations, healthy volunteers or patients, extended safety evaluation, thorough QT (TQT), drug-drug interaction, methodology
• International network of Clinical Pharmacology Units (CPUs) that have demonstrated capabilities
• Collaboration with proven bioanalytical, safety, biomarker and PD assessment laboratories internationally
• Regulatory documentation preparation for agency pre-meetings, IND/IMPD, CTA and safety summaries for filing

At GRS, the safety of each subject is paramount in all studies. The project and data management teams work closely with the safety team to track data in real-time and monitor for less obvious trends and safety issues. GRS manages independent Safety Monitoring Boards that are well organized and committed to challenging timelines in order to allow dose escalation, multiple dosing, cohort expansion and other safety-driven milestones.

We also understand preclinical pharmacokinetics (PK) and its value in predicting clinical profiles, timing of blood and urine sampling and possible PK interactions of one compound with another. We have experience with trusted, GLP bioanalytical laboratories capable of method transfer and full scale clinical assay and reporting. We have statisticians who are accomplished in the field of PK analysis and, when required, preferred relationships with kineticists for complex multi-compartment analysis.

All early phase protocols contain some assessment for pharmacodynamics (PD) including safety. Virtually all Phase I protocols now contain specific PD assessments through biomarkers or assessment of expected effect. The GRS staff has extensive experience in examining PD in early trials and has access to experienced CPUs used to procedures previously thought more appropriate to later phase development. In addition, we have established working relationships with GLP and/or GCP vendors for the assay, assessment and analysis of PD data in early stage protocols.

We know you understand that the key to a successful relationship with your CRO is governed by the team supporting you, their ability to do what they say they will do and to participate in open communication, no matter what the challenges. All Sponsors need to know that their study is just as important to their CRO team as it is to them. GRS has a specialist directing all EPDS studies, working within a team who is dedicated to accomplishing the goals of these trials. You just have to talk to us to recognize the knowledge, understanding, motivation and commitment that the team can bring to your studies.