MolecularMD is both CLIA approved (Clinical Laboratory Improvement Amendments) and CAP accredited (College of American Pathologist). The addition of the CAP accreditation helps to improve patient safety by advancing the quality of our laboratory services through education, standard setting, and ensuring MolecularMD exceeds regulatory requirements.
MolecularMD can accommodate a broad range of sample volume requirements, from Phase I trials of 20-40 patients to large Phase III/IV international trials with thousands of patients across domestic and international trial sites.
Depending on the size of the trial, we are able to customize our processes to best meet the required sample turnaround times and logistical requirements. Smaller trials may require monitoring a range of markers with customized sample preparation protocols and multiplex detection techniques. Larger trials, on the other hand, can take advantage of automated sample preparation technologies and high-throughput sequencing methods.
Whatever the testing capacity, MolecularMD can achieve the volume and accuracy needed to help clinical trials run at peak efficiency.
MolecularMD maintains an Information Technology (IT) infrastructure designed to meet the specific data management needs of clinical trials. This IT infrastructure is comprised of corporate-grade on-site and off-site data centers and a fully validated clinical data management system employing Microsoft SQL server.
All data is handled under 21 CFR part 11 (Code of Federal Regulation for Electronic Records and Signatures) and 21 CFR part 58 (Good Laboratory Practice Regulations) compliance. Comprehensive data backup protocols and disaster recovery plans ensure that the data is secure and properly maintained. The MolecularMD IT infrastructure is fully documented for easy assessment by our clinical trial service clients.
We understand that one type of test report may not meet the needs of all clinical trials. Frequently, graphical displays and interpretation guidelines are required to ensure proper patient management and clear communication among all trial participants. MolecularMD offers customized test report designs and distribution capabilities that best meet the needs of the physicians and the trial itself.
MolecularMD requires that all employees are HIPAA trained and compliant. We document all employee training and verify that the training is updated annually. This helps ensure that patient data is handled properly according to patient privacy guidelines.