Pioneering Clinical Research Since 1997
Innovation & Quality
Digital Advancements
At Pharma Medica, we are pioneers in the delivery of innovative clinical research services. We have integrated automated data capture and data assurance into every stage of our clinical trials. Our proprietary software and controls are engineered to minimize human error and to ensure data of the highest quality, from its acquisition in our clinic, sample processing by our laboratory, and analysis by our subject matter experts, through to its presentation in regulatory and guidance compliant reports.
Global Compliance & Recognition
Pharma Medica's Quality Management System has fundamentally contributed to our long-standing track record of successfully passing regulatory inspections and Sponsor audits. Our internal organizational performance measures provide a robust framework that guarantees the delivery of regulatory compliant services, certain to exceed expectations.
Clinical Services
Innovative Clinical Expertise
Pharma Medica has experience with a vast range of clinical trials, evaluating safety, efficacy and quality of medical treatments across all therapeutic areas. Our expertise lies in designing and executing well-controlled trials, collecting and analyzing data, and contributing to the advancement of new drugs and medical interventions.
State of the Art Facility
Standing at an impressive 115,000+ square feet of space, with 360 beds, including a 24-hospital bed Phase I Unit, we have the capacity to accommodate large-scale studies with full process adherence and compliance using automated data capture.
Bioanalytical Services
Capabilities
At the center of our laboratory operations is our Laboratory Data Management System (LDMS). This elaborate system was developed and validated in-house to electronically capture all analytical activities from sample accession to final reported results, not only eliminating human error but expediting the output of analytical data. Our proprietary system was built with full audit trail capabilities and FDA 21 CFR Part 11 compliance.
Expertise
Our bioanalytical team is comprised of seasoned experts, with extensive experience in bioanalytical science. Our analytical processes strictly adhere to internal curated SOPs and global regulatory requirements. Pharma Medica holds a prominent role within the field of bioanalysis as a Topic Leader for ICH M10 and other active global affiliations, such as the Global CRO Council (GCC). This underscores our commitment and contribution to pioneering innovation and setting industry standards.
Scientific Affairs
Clinical Trial Design & 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 improve processes 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.
Data Analysis
Pharma Medica’s Scientific Affairs team consists of pharmacokinetic scientists, clinical pharmacologists, biostatisticians, SAS programmers, and clinical data managers. Our experts are highly experienced across all therapeutic areas and regulatory submissions for New Chemical Entities, Hybrid/Value Added Medicine/505(b)(2) and generic formulations. We deliver high quality statistically sound outputs for data-driven decision making. We work with our Sponsors to develop a clear path for regulatory submissions and to guide future drug development research.