Program Management
Dedicated Project Managers
To facilitate a smooth project flow from initiation through the issuance of the final study report, QPS assigns a dedicated project manager (PM) to assist you every step of the way.
The PM serves as a liaison between you and our internal technical staff to handle everything from questions regarding the study proposal to concerns about timelines. To ensure that you receive your data on time, the PM will verify that your study requirements are known to the technical staff, internal processes are properly scheduled, the report is written using the correct template, and at study completion, all of the study materials are properly archived. You will have a single, direct contact point for all your study-specific questions, ensuring a rapid response.
QPS’ philosophy of individualized project management allows us to specialize in extremely intensive studies where no detail is too small.
Sample Management
Clinical Sample Collection Integrity
At QPS Bio-Kinetic, we pride ourselves on our ability to collect clinical samples correctly and on-time — every time. Our experienced clinical team of investigators, nurses, phlebotomists and technicians follow processes and systems that fit your requirements and protocol. In addition, each separate clinical unit has its own collection, processing and freezer areas. Finally, because sample collection in general and good blood collection in particular can be seen as an art form, we assign the same phlebotomist to collect samples for every time-point on the study where possible. Additionally, the same phlebotomist processes the samples, if allowed per protocol.
Clinical Sample Storage and Shipping Integrity
Sample collection is just one part of a sample integrity chain that also includes sample storage, proper reconciliation and shipment of samples. QPS Bio-Kinetic has temperature monitors in every refrigerator and freezer to help ensure samples are properly maintained to protocol requirements. The QPS Bio-Kinetic shipping process includes two phlebotomists, one of whom typically collects the samples, physically examining each sample during packaging. The director of clinical operations oversees the inventory, packaging and shipment of coolers to the designated labs.
Sample Receiving and Storage Integrity
A dedicated Sample Coordination Team (SCT) at our Delaware facility ensures that all samples received from our own clinic or external partners are inspected and inventoried immediately upon arrival. Any discrepancies are noted and shared with our clients and the clinical facility to ensure prompt resolution; we require that any discrepancies are resolved prior to analysis. Samples are then entered into our Watson LIMS. Once all sample receipt documentation is reviewed for accuracy, procedures and information pertaining to sample chain of custody are initiated in accordance with our SOPs, and study protocols are followed regarding storage conditions. Sample freezers are continuously monitored by the Rees Monitoring System with remote access capability so that equipment can be attended to even during non-business hours. In the event of a power loss, all freezers and refrigerators are supported by a back-up generator that runs on natural gas fed by a pipeline. Our friendly and knowledgeable SCT staff can be relied upon for prompt answers to your inquiries.
Data Management
Whether you subcontract your clinical data management to a third-party vendor or handle it yourself, QPS can provide you with PK concentration data in the format you need. As a value-added service, we can generate output according to nearly any data transfer specifications. This includes the transfer of clinical parameters such as sample collection dates, sample collection times, accession numbers and other variables. We have successfully assisted many sponsors in completing multi-site, international, late-phase clinical programs with exhaustive sample reconciliation procedures. Not only are we renowned for our high quality data, we can deliver it in any format that you prefer.
