Clinical Trial Project Management

The QCTLINK Clinical Project Manager is the team leader and serves as the Sponsor liaison and works to create the best suited team for each clinical program

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 thorough 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.

KEY ADVANTAGES TO PARTNERING WITH QCTLINK CLINICAL FOR CLINICAL TRIAL PROJECT MANAGEMENT INCLUDE:

• Full SOPs (Standard Operating Procedures)
• Study & site startup activities
• Documents and Submissions
• IRB/EC meeting activity
• Contracts & budgets
• Screening and enrollment
• Study subject activity throughout the trial
• Regulatory documents (electronic and hard-copy)
• Monitoring visit Reports, calendars and schedules
• Safety Reporting

With more than 10 years of clinical payments experience in local and multinational clinical trials, we have successfully managed clinical site & Investigator payments with a comprehensive understanding of clinical trial budgets, finance and accounting specific to clinical studies.

Eclipse™ is a clinical payment service customized for each Sponsor and study to ensure that you will receive personalized service from our payment team.

• Clinical sites can be initiated quickly when start-up payments are efficiently disbursed
• EDC data used to determine which visits should be paid
• Easy-to-read Site Statements that provide Sponsors and sites with detailed listings on a subject visit level, as well as a historical record of all payments made to date
• Payment Analysts ensures that payments are made within the terms of the clinical trial agreements and, based on EDC data
• Single point of contact for sites
• Monthly accrual reporting and expense forecasting as well as support for Financial Statement audits.
• Sponsor cash flow is optimized by real-time funding
• Developed and current full SOPs (Standard Operating Procedures)

Clinical Site Monitoring:

Exceptionally trained, regionally based Clinical Research Associates (CRAs) with an average of 10+ years clinical trial industry experience and over 1,000 site visits in the past three years.

KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR CLINICAL SITE MONITORING:

• PRC Clinical CRAs ensure that for every project, investigators are appropriately selected and trained to complete the study following GCP and ICH guidelines in order to produce high-quality study results.
• Familiar with all EDC platforms
• Our CRAs maintain a strong relationship with each study site, ensuring absolute quality and on-time receipt of all clinical trial deliverables.
• Site focused CRAs that integrate with Sponsor teams and facilitate communication between sites and sponsors
• Supported by ongoing trainings to remain current with industry content and trends
• Developed and maintained full SOPs (Standard Operating Procedures).

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.

KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR CLINICAL DATA MANAGEMENT (CDM) INCLUDE:

• Extensive libraries of standard eCRFs & edit checks
• Experienced, driven project teams that require minimal oversight from Sponsors
• Seamless interaction between Data Management and Clinical Operations teams
• Expedited study start-up & close-out timelines
• Developing and regularly updating full SOPs (Standard Operating Procedures)

OUR CLINICAL DATA MANAGEMENT (CDM) SERVICES INCLUDE:

• Data Management Trial Master File Set-Up and Maintenance
• eCRF / CRF Design and Development
• CRF and Diary Completion Instructions
• Subject Diary Design and Development
• Data Management Plan Development
• Data Validation Manual Development
• Edit Check Programming, Validation, & Testing
• Clinical Database Creation, Validation, & Testing
• EDC System Training for Sites & Monitors
• Adverse Event and Concomitant Medication, and Medical History Coding
• Import, Integration, and Cleaning of electronic data (Lab, ECG, PK, Diary, etc)
• Independent QC Review
• SAE Reconciliation between Safety and Clinical Databases
• Development of Custom Status Reports
• 24/7 EDC Helpdesk

Safety Services:

Our strategic relationship with Drug Safety Management partners enables 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.

KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR DRUG SAFETY INCLUDE:

• Experienced Drug Safety staff
• Development of Safety Monitoring Plan
• SAE notifications to sites and sponsor within 24 hours
• Development of Safety Narrative Template
• Full SOPs (Standard Operating Procedures)

DRUG SAFETY MANAGEMENT SERVICES FOR YOUR CLINICAL TRIALS INCLUDE:

• Serious Adverse Event (SAE) collection and reporting
• Subject Narratives
• Safety Database
• Database Reconciliation
• Safety Data Review
• Investigator and Ethic Committee safety notifications
• Annual reporting (IND, EU ASR, and DSURs)

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.

KEY ADVANTAGES TO PARTNERING WITH PRC CLINICAL FOR QUALITY ASSURANCE AND COMPLIANCE INCLUDE:

• Compliance staff is well versed in ICH Guidance for Industry, Good Clinical Practice, and Good Laboratory Practice
• Detailed Audit Plan which is reviewed and approved by you before the audit
• Audit report provided with 10 working days following the audit
• Full SOPs (Standard Operating Procedures).

QUALITY ASSURANCE AND REGULATORY COMPLIANCE SERVICES FOR YOUR CLINICAL TRIALS INCLUDE:

• Investigator Site Audit
• Clinical Report Audit
• Protocol Development Audit
• Investigator Brochure Audit
• Clinical Laboratory Audit
• Vendor Audit