Phase II-IV Clinical Trials:
Clinical Trial Management and Monitoring

Clinical Trial Site Qualification and Monitoring
RCRS provides Clinical Monitoring services via office-based and regional Clinical Research Associates with a smooth flow of active communication amongst project team members. The Site Monitors are ICH-GCP trained and provided with trial specific and Sponsor's SOP training (if required). The approach of each site monitor is for 'site oversight- they are responsible for the efficient supervision of the site team, site team personnel training , the resources available at the site, and the timelines set for the study milestones at the site.

The site qualification process ensures that sites meet the necessary requirements of the trial prior to study site initiation. RCRS has an extensive database of investigators in several disease domains that consist of physicians with extensive clinical trial experience. These investigators have the appropriate facilities and qualified support personnel, and are audited and approved by RCRS and thoroughly trained in Good Clinical Practices as well as on trial procedures and requirements.

RCRS offers high quality solutions driven by the combination of clinical trial expertise and resources that facilitate the collection and review of paper or electronic patient data in clinical trials.

Study monitoring services offered by RCRS are tailored to meet the objectives, design and requirements of Sponsors, and are characterized by planning, versatility, reliability, scalability, and the ability to interface with other participating vendors, all in compliance with stringent confidentiality and applicable local regulatory standards.

Clinical Trial Supplies Management
RCRS offers facilities and consultation for drug storage, inventory, and temperature-controlled transport for clinical trial supplies such as pharmaceuticals, vaccines, biologicals, devices, laboratory kits and equipment. These services are also compatible with the use of centralized randomization, drug assignment, and blinding techniques.

Clinical supplies are stored under customer-specified conditions with complete access control and disaster management and recovery processes. Supply distribution is tracked through delivery to sites in accordance with RCRS SOPs. Storage areas designated for drugs and biologicals are maintained at ambient, refrigerated or frozen conditions with 24x7 temperature monitoring and back-up power supply. RCRS also arranges for return and/or destruction of expired, unused and damaged trial supplies under customer-specified conditions.

RCRS also has readily available storage for samples at the following temperatures: ambient, refrigerated, and frozen at -20oC, -70oC or -80oC. Samples and materials that RCRS can store include genomic DNA, Plasma, serum, CSF, bone marrow, tissue specimens and biopsies.