The PROMETRIKA team has proven expertise in the full range of specialized CRO services necessary for phase 1 studies including pharmacokinetic and pharmacodynamic (PK / PD) studies, first-in-man and dose escalation studies. Our project managers, clinical monitors, and data managers have extensive experience working with phase 1 units and specialty core laboratories in the U.S. and abroad.
Our statisticians have conducted numerous analyses of PK and PD parameters as well as specialized phase 1 studies including thorough QTc studies. We can conduct statistical analyses based on available PK and PD parameters, or calculate parameters based on plasma or urine concentration data using WinNonlin® or our own SAS® programs. Our team of specialists has developed customized programs to perform PK/PD modeling and to evaluate dose-proportionality. The PROMETRIKA medical writing staff has extensive experience and expertise in authoring CSRs for phase 1 studies in collaboration with our expert PK / PD consultants.
Phase 2 and 3:
PROMETRIKA has successfully planned and executed phase 2 and phase 3 clinical studies in every major therapeutic area. Members of the PROMETRIKA team have collectively managed hundreds of studies in drugs, biologics, and devices with outstanding strategic insight and perspective.
PROMETRIKA has provided sponsors with expert analyses that establish proof-of-concept, dose-response, efficacy, safety, and long-term safety. Our sponsors’ confidence in PROMETRIKA’s expertise has resulted in our participation in specialty studies that have included renal and hepatic effects, onset and duration of effect, population PK sub-studies, and randomized withdrawal (“rebound effect”).
The Clinical Operations team at PROMETRIKA is versed in risk-based, targeted source document verification. As a Medidata Rave partner, we are poised to build robust databases capable of capturing and validating large volumes of complex clinical data. And PROMETRIKA’s biostatisticians provide our sponsors with extensive knowledge in the design and analysis of superiority, non-inferiority, enriched population, and adaptive design trials.
PROMETRIKA’s comprehensive phase 4 services focus on helping our sponsors in their efforts to build product awareness, investigate new indications, and fulfill post-marketing regulatory commitments. In addition to traditional phase 4 clinical trials, PROMETRIKA designs and manages non-randomized observational trials and global patient registries.
For more than a decade, PROMETRIKA has worked closely with medical affairs and marketing teams in large and small biopharmaceutical companies, developing the necessary methodologies and perspectives required to meet the unique challenges in the design and implementation of post-marketing strategies.