Oncology Biomarker Diagnostics

Linking molecular status to breakthroughs in cancer treatment

Clinical Trial Services

Contact MolecularMD for more information about our Clinical Trial Services.

Assay Development

MolecularMD specializes in developing RNA, DNA and IHC-based assays for biomarker research in oncology drug development. Extensive analytical validation of each assay ensures robust performance and accuracy. Multiple technology platforms are available for detection of mutations, copy number variations, translocations and expression levels. Assays are optimized for use with limited tumor tissue while providing the maximal data content, sensitivity and turn-around-time that is required to meet a sponsor’s clinical study.

Customized Reporting

One test report format 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 sponsors and trial investigators. MolecularMD offers customized test report designs and distribution capabilities that best meet the needs of the sponsor, investigators and regulators.

Trial Site Support

The MolecularMD clinical trial support team provides a wide variety of customized trial support services to accommodate the unique logistics and reporting requirements of a sponsor’s trial. A team of clinical trial support specialists is assigned to each trial and maintains a detailed working knowledge on all aspects of the trial, from sample submission to data reporting. In addition, clinical trial project managers are available to travel to the clinical trial sites for hands-on training and support.

Investigator Education

MolecularMD offers in-depth physician education programs that cover testing protocols, data interpretation and the various molecular diagnostic tests employed in a particular trial. As part of the training, our project managers and trial experts may attend investigator meetings as requested. Our goal is to ensure that MolecularMD protocols and reported results satisfy all expectations of the sponsor and trial investigators.

Laboratory Certification

MolecularMD’s laboratory is both CLIA-certified (Clinical Laboratory Improvement Amendments) and CAP-accredited (College of American Pathologists). MolecularMD requires that all employees are HIPAA trained and compliant.

Test Capacity

MolecularMD undertakes biomarker studies of various scope and scale ranging from Pre-Clinical and Phase I exploratory studies to larger international Phase III/IV pivotal trials. Processes are optimized to best meet the required sample turnaround times and logistics. Whatever the study design, MolecularMD can achieve the turn-around time and reporting accuracy needed to help clinical trials run at peak efficiency.

Data Management

MolecularMD maintains an Information Technology (IT) infrastructure comprising 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.

Clinical Trial IUO Kits

The MolecularMD Clinical Laboratory offers the following sensitive, reproducible and highly specific mutation analysis and expression analysis testing to aid in patient selection for appropriate Clinical Trial/IUO Assay and potential monitoring of treatment efficacy.

 

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