Services

Services

Clinical Operations

We Reduce Time to Market through optimization of all aspects of the clinical trial process and functional areas.

We reduce risk through milestone and performance-based agreements to move your product to the next stage towards approval within budget.

RAY Clinical Operations team conducts Phases II-IV clinical trials in various therapeutic areas for pharmaceutical and biotechnology companies, maintaining the highest standards of ethics, quality and confidentiality.
  • RAY provides regulatory consulting as a customized stand-alone service or through our full service clinical trials. We can advise sponsors with strategic planning, development, evaluation, and preparation of regulatory submissions at all stages of development and post-marketing.
  • In order to optimize the timelines, we have Submission Associates, dedicated to preparing submission files and establishing privileged relationships with Competent Authorities.
  • RAY Clinical Project Management will oversee all aspects of study conduct, including vendor management, from initiation through closeout, using project management skills to drive a project process to completion.
  • This includes but is not limited to establishing and setting project timelines, milestones and action items, determining project resources, developing internal and external status reports, identify operational issues and facilitating their resolution, and tracking and managing project schedules and status.
  • All projects are efficiently handled by qualified project managers who are experienced in various therapeutic areas.
Site Management:

Feasibility and Site Selection Services:
  • Country feasibility, site and investigator selections are crucial steps for any clinical trials, as it impacts the study for its whole duration.
  • Effective site management is a cornerstone of every successful research program, RAY Clinical Operations team selects each study site based on the site infrastructure and access to appropriate patient population. A recruitment and retention plan unique to each site is prepared, focusing on the site's strengths and experience
  • We provide a professional Site training, study education and GCP training to speed IRB submission and approval, and to facilitate patient selection, enrolment and randomization
  • Detailed procedures ensure monitoring of site performance and withdrawal of non-performing or non-compliant Investigators to avoid delays in database lock or analytical deadlines.
  • RAY Clinical Operations team conducts Phases II-IV clinical trials for pharmaceutical and biotechnology companies, maintaining the highest standards of ethics, quality and confidentiality
  • We are Expertise in clinical trial management
  • RAY provides end-to-end management of clinical and ancillary supplies. Our team develops a customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to  SOPs of sponsor and regulatory guidelines.
Monitoring Services:

We have highly proficient monitoring staff each member is fully trained on ICH guidelines, and GCP/SOP compliance, experienced in conducting site evaluation visits, site initiation visits, periodic monitoring visits, and study termination visits as well as all in-house monitoring functions, including adverse events reporting, and clinical trial material management.
 
Our Clinical Monitoring capabilities include:
  • Identification and selection of investigators
  • Identification and management of IEC/IRB
  • Regulatory document review and collection
  • Review of study documents ,source data verification, Case Report Forms and Informed Consent Forms
  • Site contract, budget negotiation, and grant administration
  • On-site training
  • Site qualification, initiation, and closeout
  • Interim site monitoring
  • Handling protocol deviations
  • Providing protocol waivers, wherever acceptable
  • Drug accountability
  • Second clinical review
  • Data query resolution
  • A customized logistics model to meet the unique needs of the sponsor, while ensuring adherence to SOPs of sponsor and regulatory guidelines.
  • Our service begins with providing assistance in obtaining import license and custom clearance of clinical supplies. Depending on the requirements of the sponsor, we also take the responsibility of drug destruction.