Our full range of clinical trial development and management services include:
Protocol Development and Project Management.Research protocol specialists oversee scientific protocol development and study management from initial concept development to final data collection.
Site Identification, Management, and Audit.ACCRU provides complete site management, including site selection, continuous site monitoring and periodic site audits.
Patient Enrollment and Data Management.Experienced data management personnel enroll patients, collect clinical trial data, and ensure quality control.
Regulatory Management.ACCRU’s experienced staff, regulatory document management system and quality assurance procedures ensure that all clinical trial regulatory requirements are fulfilled using a streamlined, cost-efficient system. This includes:
- Maintaining general and study-specific personnel and institutional regulatory documents for all network members;
- Facilitating completion of study-specific regulatory requirements; and
- Managing investigational new drug (IND) regulatory forms and data submission requirements.
Electronic Clinical Trial Data Systems.This includes:
- Patient registration — Remote registration and randomization systems validate Institutional Review Board (IRB) approval, patient eligibility and user access; and
- Remote data capture and real-time quality assurance — electronic data systems capture clinical trial data and provide protocol-specific query lists, data timeline standards, online reporting, and an automated real-time toxicity monitoring system. Electronic data collection is through the Medidata RAVE system, a 21 CFR Part 11-compliant industry standard.
Biostatistics.ACCRU provides full-service (initial concept through final reporting) biostatistics. Our staff includes nine ACCRU-affiliated Ph.D. biostatisticians and a statistical group of over 40 statisticians, all with expertise in supporting clinical trials phase I-IV. ACCRU statisticians have extensive experience working with the FDA and maintaining a wide-ranging portfolio of methodological work in clinical trial design, biomarker-based trials, survival analysis, endpoint assessment, and evaluation of patient reported outcomes.
Pharmacy Services.ACCRU offers a central pharmacy service, along with quality-control systems for medication order fulfillment, shipment, and reconciliation.
Looking for Something Else?This is a general list of ACCRU research services. If you have a specific question about a service that is missing from our list, please Contact Us.