Laboratory Solutions for Decentralized Clinical Trials

In the context of today's environment, hybrid and decentralized clinical trial models are becoming increasingly prevalent. Methods such as remote recruitment and data collection, options for collecting samples close to or at home, and connected devices make it easier for patients, caregivers, and study staff to take part in clinical trials.

At IQVIA Laboratories, our decentralized clinical laboratory solutions deliver the same quality of service as our central laboratory services but with a decentralized approach, including the necessary logistical and operational support required to conduct research remotely.

With a decentralized approach, patients, caregivers, and study staff can participate in trials more easily due to methods like remote recruitment and data collection, options for collecting samples close to or at home, and connected devices.

Self-Collection of Specimens

Self-collection of specimens involves sending specimen collection devices directly to patients. Patients collect their own specimens and send the devices with the specimens to a laboratory for testing. At IQVIA Laboratories, we are partnering with several self-collection device manufacturers to build a validated menu to support these collection modalities.

 
Read our Self-collection of Blood Specimens in Clinical Trials in Applied Clinical Trials or visit our Patient Self-Collection webpage to learn more.

Point-of-Care Testing

Incorporation of laboratory point of care testing (POCT) testing in clinical trials is increasing. POCT devices have been deployed at investigator sites to screen and enroll a patient in a single visit, help reduce screen failure rates via a pre-screening step, and provide for results more rapidly than local labs. However, in these examples POC devices were not integrated with the clinical trial laboratory, and the data was not used for regulatory submissions. We have connected POCT devices to our central laboratory systems to enable viewing of laboratory reports by medical monitors and data transfers to study teams.

Our lessons learned are available via our Point of Care Testing article in Applied Clinical Trials and visit our Point of Care Testing webpage to learn more.

Mobile Specimen Collection

To support decentralized trials, and to enable convenience for patients, we have partnered with mobile nurse and phlebotomy companies to support in home specimen collection, as well as specimen collection at Quest Diagnostic patient service centers (PSCs) in the United States. We have managed laboratory testing for dozens of studies utilizing Near Patient Collection services across many therapeutic areas.

Visit our Mobile Specimen Collection webpage to learn more.

Direct to Patient (DTP) Kit Shipments

As self-collection and home healthcare become more prevalent in clinical trials, so does the interest in shipping specimen collection kits directly to patients’ homes. The IQVIA Laboratories DTP Kit Distribution service enables specimen collection kits to be shipped directly to patients on behalf of clinical trial investigators, while taking great care to properly manage sensitive patient protected health information (PHI).