Tailored Clinical Trial Solutions
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Clinical Research Solutions
We offer a wide range of services for biotech, pharma and device clinical trials. From full-service to functional and à la carte trial support, we are experts in complex trials, pharmaceutical and regenerative medicine products, combining the best possible CRO experience with the highest quality data.
PRC is a leading CRO in clinical trial project management for first-in-human and early phase studies. Our team has a deep understanding of the science and regulatory requirements involved in these complex studies focused on patient safety, often requiring collection of pharmacokinetic (PK) and pharmacodynamic (PD) data in healthy volunteers and patients alike. We partner with specialty clinics and labs and oversee all aspects of data collection and pharmacovigilance reporting and can conduct or manage the Data Safety Monitoring Board (DSMB) of Safety Review Committee (SRC) meetings often required in these intensive trials.
PRC has a proven track record of clinical trial management, successfully advancing Phase I studies to the next stages of development, including Phase II and Phase IIb. Our experienced team routinely supports the increased logistical requirements as well as coordinating other data collection tools, instruments and equipment necessary for studies with 2-50+ trial sites.
Our clinical trial project management expertise shines in our scalability and ability to support North American Phase III studies or part of the “boots on the ground” regional approach. We have supported many Phase III trials as large trials and smaller rare disease trials.
As a coordinating CRO, we act as an integrated global partner to ensure the success of your clinical trials, no matter the size.
Our full-service model ensures consistency across functions, guided by an integrated team of experts to manage clinical operations, data management, safety and laboratories. From feasibility to startup to database lock, sponsors trust PRC to provide proven expertise to achieve your trial’s goals.
PRC is able to offer specific and specialized support for certain areas of your trial; our functional services offer trial support where you need it. Our menu approach to service let our sponsor retain control and outsource the expertise they need to ensure site management, data services, clinical operation and other needs are fully met.
PRC’s comprehensive clinical trial management support of ancillary service providers prioritizes remote trial work to minimize risks associated with decentralized operations. Our approach involves carefully selecting services that can be conducted remotely while maintaining an in-person workforce for other critical services.
Our Services
Study Management
With a range of customized clinical trial management services, our clinical operations study teams provide hands-on guidance, quality assurance and day-to-day support to meet milestones on time and on budget. From choosing the right sites and oversight throughout the project, we are here to help.
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eTMF & Document Management
We have elevated our electronic document management (eTMF) services to a state-of-the-art process that is central to a successfully documented clinical trial. eTMF support is available as a stand-alone service to support any trial.
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Study Monitoring
With PRC’s study monitoring support, you’ll be receiving the highest level of attention and care from our dedicated in-house and regional teams. We take great pride in providing our customers with exceptional service and support, and we’re confident that you’ll be more than satisfied with the premium experience you’ll receive.
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Coordination & Logistics
PRC’s clinical trial project management support is flexible and can manage other study vendors with seamless team communication and overall deliverables. PRC’s additional service vendors include licensure procurement, specimen, cell and gene cryo-shipping and specialty laboratory services required for the trial.
Read MoreConsulting
Clinical trials are a crucial step in bringing new medical treatments to market. However, navigating the complex regulatory landscape can be challenging. That’s where our clinical trial consulting services come in. We provide expert guidance and support to help ensure your trial is a success. Contact us today to learn more.
Protocol Development
Looking to develop a study protocol for your clinical trial? Our team of experts works closely with sponsors to ensure all required elements are included, from the study synopsis to regulatory input, medical writing and biostatistics. Trust us to help you bring your clinical trial to life.
Trial Optimization
Looking to optimize your clinical study and data output? Our team of clinical trial management experts can review your study protocols, documents and processes to ensure the best possible results. Contact us today to learn more about how we can help you achieve success in your clinical trials.
Leading Clinical Trial Management Technologies
Feasibility Database
PRC’s proprietary database allows for accurate assessment of the competitive landscape and provides up-to-date site enrollment estimates. With access to real-world data, PRC can provide valuable insights to help inform decision-making and drive success.
Industry Intelligence
Our web tools and technologies provide us with actionable intelligence and insight into industry trends in biotech and pharma research. Understanding this data can help with regulatory meetings, funding trends and public perception of clinical trials.
Salesforce CTMS
Our CTMS is built on the Salesforce platform and provides a comprehensive suite of management software and reports. With a focus on study metrics, analytics and ongoing development, it offers a powerful solution for sponsors to streamline their reporting and insight.
Artificial Intelligence
PRC’s advanced tools incorporate AI to aid in site and PI searches, as well as performance metrics to assist sponsors in predicting enrollment and gaining insight into high-performing sites.