In Vitro Diagnostic Development

Consultation for the IVD Industry

Clinical trial protocol design

The strategy behind the science in developing a strong clinical trial protocol is learned only through experience. Our staff has over 25 years in developing successful clinical trials that will maximize operational efficiency and reduce the risk of repeating time-consuming trials. Additionally, compliance with regulatory agency requirements and expectations for a clinical trial protocol is an essential design feature of a strong protocol. Our experience in clinical trial design will be applied to your project and will be instrumental in preventing timely delays during the post-submission review process.

Clinical site identification and qualification

Identifying and recruiting qualified clinical trial investigators is perhaps the most important element of the clinical trial endeavor. With committed and qualified investigators performing the clinical trial, the probability of investigator error or low subject recruitment is minimized. Our team has identified numerous investigators for a wide range of IVD and medical device clinical trials.

Clinical site management

How an accrual site actually performs during the clinical trial is a vital element to overall product registration. Slow recruitment? Protocol violations? Our team of experienced trial monitors can provide assistance to clinical investigators who are experiencing problems with the trial. GLAS can find the solutions.

 

Conduct of clinical trials

GLAS has experience in conducting in vitro diagnostic and medical device clinical trials. With an experienced medical and scientific staff, your clinical trial will be conducted properly from the start. Included in our expertise is creation of consent forms and all required IRB functions. Laboratory testing is performed in our new laboratory.

Sourcing of clinical specimens for analytical studies and product development activities

Having problems locating hard to find specimens? GLAS is experienced in sourcing biological specimens for research purposes. Focused on oncology and infectious disease, GLAS can provide a wide range of specimens, all collected with demographic information essential to support Phase II development activities.

Request In Vitro Diagnostic Services

pathology consulting

Consult with Pathology Experts

We are a group of forward thinking, seasoned medical pathologists, scientists and laboratorians. We are passionate about furthering impactful research and enabling our peers to reach their goals. We offer our consultation services to contribute to every step of your project including goal setting, design, and execution. From the first conference call to project completion and beyond you will interact with our board certified pathologists directly. This will ensure on-target project delivery that consistently exceeds expectations.

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