Scientific Affairs
Pharma Medica’s Scientific Affairs team is comprised of experts whose knowledge spans the breadth of the pharmaceutical and medical sciences. Our scientists have advanced degrees in pharmacy, pharmacology, life sciences, biostatistics, and more. Our team is well positioned to handle your scientific needs from clinical trial design, protocol development, sample size estimation, data analysis, and reporting. Our subject matter experts are involved in every aspect of trial design, working with you to help achieve a successful outcome for your study.
Clinical Trial Design and Reporting
Clinical Trial Design and Reporting
Pharma Medica designs clinical trials and develops clinical protocols in a collaborative process that draws on our clinical and bioanalytical experts and from an extensive in-house library of data. Our study designs are continually evolving to incorporate new data and analysis methods, updates in regulations, and proactively mitigate risk. The collaborative process continues through to the finalization of the clinical study report, ensuring an accurate, comprehensive presentation of findings and analysis. Pharma Medica’s all-inclusive package provides quick, cost-effective, submission-ready study deliverables that comply with regulatory and guidance requirements.
Innovative Study Designs
Innovative Study Designs
Pharma Medica devises innovative study designs based on strategic development and planning. We have an exceptional track record conducting Pharmacokinetic (PK) Studies to evaluate the comparative bioavailability (BA) of novel formulations or bioequivalence (BE) between approved brand-name drugs and generic formulations. We also have experience designing, developing and conducting:
- Pharmacodynamic (PD)/Clinical Endpoint Studies;
- First-in-Human (FIH) Studies;
- Single Ascending Dose/ Multiple Ascending Dose (SAD/MAD) Studies;
- Dose Proportionality Studies;
- Adaptive Design Studies; and
- Futility Design Studies