End to End Clinical Operations
MDL provides integrated clinical research solutions spanning the entire product development and evidence-generation lifecycle. From pre-clinical research and BA/BE studies to Phase I–IV clinical trials, post-market follow-up, and registry studies, we support sponsors with scientifically rigorous and operationally efficient research solutions.
PRE-CLINICAL & REGISTRY STUDIES
We support pre-clinical research and clinical registry studies designed to generate reliable evidence for product development and real-world clinical evaluation. Our customized approach ensures robust study design, quality data collection, and meaningful evidence generation.
PHASE I–IV CLINICAL TRIALS
We support pre-clinical research and clinical registry studies designed to generate reliable evidence for product development and real-world clinical evaluation. Our customized approach ensures robust study design, quality data collection, and meaningful evidence generation.
POST-MARKET CLINICAL FOLLOW-UP (PMCF) STUDIES
We provide end-to-end support for PMCF studies to evaluate the continued safety, performance, and clinical benefits of medical devices in real-world settings. Our services cover study design, regulatory and ethics support, data collection and management, analysis, and clinical study reporting.
BA/BE STUDIES
MDL supports Bioavailability (BA) and Bioequivalence (BE) studies at our Nairobi site (MDL Clintech), covering clinical operations, bioanalytical services, pharmacokinetic and biostatistical evaluation, and regulatory documentation. We conduct fasted and fed BA/BE studies in controlled, GCP-compliant clinical environments, managing activities from volunteer recruitment and clinical monitoring through study execution. Our bioanalytical capabilities include precision-driven quantitative analysis using validated LC-MS/MS and HPLC methods, supported by comprehensive non-compartmental pharmacokinetic analysis, ANOVA, mixed-effects statistical approaches, and TOST methodology for equivalence assessment.