MolecularMD develops reliable, validated tests to meet pressing deadlines of impending clinical trials. We work closely with our pharmaceutical partners to provide validated assay protocols that are robust and meet all performance requirements while addressing the clinical objectives. To ensure that we meet rapid assay development timelines, MolecularMD maintains strong relationships with top cancer research facilities, such as Oregon Health & Science University. This allows us to maintain reliable access to disease-specific patient tumor samples.
In coordination with the trial sponsor, MolecularMD technical leaders regularly consult directly with the trial key opinion leaders (KOL) to be sure they are satisfied with test parameters and final test reports.
MolecularMD maintains a state-of-the-art molecular diagnostics research and development laboratory, led by Dr. Eric Bruening, who brings 15 years of experience in the development of specific and sensitive molecular assays. The laboratory staff consists of our Lab Director, Dr. Chad Galderisi, and a team of dedicated development scientists and technicians with expertise in implementing all phases of assay development, including reagent selection, protocol optimization, and assay validation and documentation.
Support for our clinical trial clients goes far beyond the lab and submission of the results. Often, MolecularMD supports trial logistics in the field to help ensure proper adherence to sample collection and sample shipping protocols at the trial sites. We also frequently attend clinical investigator meetings in order to present assay protocols and methodologies and assist with data interpretation.
MolecularMD is unique in that we can offer a breadth of technical expertise and clinical experience to support a trial on such a comprehensive basis.
The MolecularMD clinical trial support team is organized to help ensure that logistics and site cooperation run as smoothly as possible. To assist with this, we provide a wide variety of customized trial site support services, depending on the complexity of the sample collection protocol and the number of sites involved.
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 submission. When necessary, technical support members can travel to the clinical trial sites for hands-on training and support.
Due to the extensive range of applications and procedures for molecular diagnostic clinical testing, physician investigators often require individualized training depending on their experience and the specifications of their clinical trial. Therefore, MolecularMD offers in-depth training to key opinion leaders (KOL) on testing protocols, data interpretation and the various molecular diagnostic tests employed in a particular trial.
As part of the training, our PhD and MD level experts are available to attend KOL meetings to deliver presentations and competently answer questions and concerns raised by the physicians. Our goal is to ensure that MolecularMD protocols and reported results are in line with the expectations of the KOLs and physicians participating in the trial.