PRC Clinical

Company Overview

PRC Clinical is the CRO of choice for many pharmaceutical, biotech and regenerative medicine developers worldwide, offering a next-level clinical trial management experience. Our innovative approach to executing studies merges our high-touch human element with high-tech tools, extensive experience and deep knowledge – far exceeding the level of service offered by large CROs. We offer full Clinical Trial Management services including Clinical Project Management, Site Monitoring, Quality Assurance, Drug Safety, Payment Services, Biostatistics, Data Management, Regulatory Strategies, and Site Selection and Enrollment. PRC clinical has significant CRO experience in a wide range of therapeutic areas: Regenerative Medicine, CNS, Neurology, ALS, Parkinson’s, Pain, GI, Device, Anti-infective, Cardiovascular, Pulmonary, Oncology, Endocrine, and Stem cells.

Our clinical teams and services are customized to fit the needs of the sponsor and requirements of the study. Sponsors enjoy the transparency we offer regarding pricing and the cohesive clinical teams we offer that commit early to executing their study.

Our study teams maintain the highest level of GCP and ICH standards for every study we manage. Our resourcing model allows Sponsors to only pay for the high quality services and technologies they need.

Contact Information

Aditya Kotta
Business Development Manager
PRC Clinical
1111 Bayhill Dr, Ste. 290
San Bruno, CA 94066
USA
1-(877) 519-6001
info@prcclinical.com
www.prcclinical.com
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Therapeutic Experience

PRC Clinical has managed and supported clinical programs for many therapeutic areas with significant experience in the areas of CNS, neurology, pain, infectious disease, and musculoskeletal diseases. We have strong working relationships with many Investigators and for every study we provide an ‘A-team’ with recent relevant experience. By leveraging the team’s collective experience we offer clients advantages like lessons learned from previous studies. We have conducted many FDA regulated as well as non-registrational studies, and our staff has experience in many disease indications and therapeutic modalities. We have supported private research Industry studies, as well as grant funded National Institute of Health (NIH) programs. Our team has been involved in both small and large clinical programs, from orphan drug designated trials to large clinical registries of 3000+ patients.

Clinical Services

Clinical Trial Management

PRC Clinical has the resources to assemble custom teams of experts for every clinical trial project. We carefully review every protocol and invest time and resources in building the best possible team for each clinical program we manage. We take the time to identify the needs of Sponsors and we know how to best apply the right resources needed to design, plan, and execute each unique clinical program. We are sensitive to the key cost drivers in clinical trials and experts at identifying the potential challenges Sponsors and their investors may face before a trial begins. Sponsors turn to PRC Clinical to manage their trial because of our personalized approach to trial management that elevates your study as the top priority. PRC Clinical becomes an extension of the Sponsor’s clinical department and works as the ‘central hub’ driving all study functions.

Clinical Site Monitoring

PRC Clinical has a proven record of study conduct and execution that consistently meets Sponsor’s goals and reduces enrollment and database lock timelines. Our team engages early and we are able to utilize our standard forms and processes that can significantly reduce time and cost associated with study start up. We have a strong network of regional monitors located throughout North America to support trials of any size. Our Clinical Trial Management System (CTMS) centralizes study conduct and tracking by providing real-time study status and metrics to the entire study team. Essential trial documents housed securely in our offices are also available electronically in the CTMS with real-time 24/7 access.

Quality Assurance and Compliance

Our preferred partners allow us to provide quality assurance and regulatory compliance services for your clinical trials. Our quality assurance services include clinical report, protocol development, investigator brochure and clinical laboratory audits. Our compliance staff will meet and discuss your needs and scope of the services. Following the meeting a detailed audit plan is prepared which is reviewed and approved by you before the audit occurs. Following the audit and within 10 working days, a draft report which documents all findings, including deficiencies from the audit.

Drug Safety Services

Our strategic relationship with Drug Safety Management partners enable us to provide the highest quality deliverables across a wide array of clinical services. Through our preferred partners, we offer drug safety services including Serious Adverse Event (SAE) collection and reporting, subject safety narrative preparation, safety database, safety database reconciliation, and safety data review. In addition, we provide Investigator and Ethics Committee safety notifications, as well as annual reporting services such as IND, EU ASR, and DSURs.

Clinical Trial Project Management

Our project managers are extremely customer focused and directly accountable to Sponsor for all project-related responsibilities which, among others, include team coordination and training, investigator and subject recruitment, communications with sites and sponsor, project tracking and on-time reporting as well as meeting project timelines.

The Clinical Trial Project Manager manages all activities coordinated through study team meetings and communications, including study start-up activities, maintenance to study close-outs by utilizing our proprietary CTMS to report up-to-date study status, patient enrollment, site information and deadline and milestone tracking for regulatory documents and submissions.

Clinical Payment Services

Since 2003, PRC Clinical has executed thousands of transactions for pharmaceutical and biotech sponsors, calculating and delivering timely investigator payments to clinical sites worldwide. PRC Clinical has a comprehensive understanding of clinical trial agreements, study site budgets and a proven method for bridging clinical, finance and accounting perspectives specific to clinical trials. Eclipse™ is a payment service that capitalizes on the efficiency of EDC/eCRF visit data, optimizes cash flow through real-time payment ‘batch’ funding and increases financial reporting accuracy by providing monthly financial accrual reports and preparing data files for submission in compliance with Centers for Medicare and Medicaid Services (CMS) Sunshine Act/Open Payment reporting requirements.

Biostatistics

Biostatisticians play a key role in the planning and preparation of any clinical study. Our stats team can support every step of the process, from designing a cost-effective, optimal clinical study to providing the relevant statistical input on the study protocol to present it to the FDA and other regulatory agencies.

Clinical Data Management

We recognize that data integrity is the key to success of any clinical study, whether your trial is a large international study or a single center proof-of-concept trial. Working together with our partners we provide a seamless flow of data and constant communication to meet all project deadlines and milestones. Our data management experts understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.

Clinical Trial Management Systems (CTMS)

We take timelines seriously and work side by side with Sponsors and colleagues to ensure the most efficient path possible while being mindful of duplicated efforts. PRC Clinical utilizes our CTMS to support efficient team communication and assist with planning, managing and reporting overall study timelines.

Real-time study data is available for viewing online via web-based CTMS access and can be granted by role ("Sponsor", "Project Manager", "Regional CRA") to any team member.

Our CTMS can interface with various EDC and IRT (IWRS randomization) platforms, Central Laboratories, and other study services seamlessly to provide real-time study information and metrics in one, easy to use location. It is 21 CFR Part 11 Compliant.

Contact Information

Aditya Kotta
Business Development Manager
PRC Clinical
1111 Bayhill Dr, Ste. 290
San Bruno, CA 94066
USA
1-(877) 519-6001
info@prcclinical.com
www.prcclinical.com
View Map

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