Clinical Trial Management Services

Clinical Trial Management Services

Clinical Trial Management Services

One of the greatest challenges associated with any trial is quickly initiating the project or risk, losing valuable time and money. IBCR understands the importance of accelerating this process. That’s why we’ve structured ourselves in a novel way that streamlines fastest project deliverables based on client’s requirement.

IBCR is built on a strong knowledge base ensuring effective project planning and project implementation. Our clinical execution team has substantive experience in conducting ICH-GCP studies in India and its neighbor countries. The group has growth plans that include multiple offices and regional investigators working for CIRMO model across globe. IBCR has therefore formulated a number of implementation strategies in order to maximize the successful delivery of project timeline and the study as a whole.

Support services

IBCR understand our client’s world and will continuously focus to provide innovative solutions to alleviate the risk involved in the planning and execution of clinical trial projects. We provide clinical services in the following area;

  • Investigator Relations
  • Clinical project feasibility
  • Clinical Trial Management Services (Site selection, Clinical trail execution, Site management)
  • Clinical Writing / Research publication
  • Clinical Quality Assurance
  • Central Ethics Committee
  • Skill Development Trainings
  • Clinical trial resource
  • Central archival of clinical data

Therapeutic Expertise:

Our IBCR investigators has more than 10 years experience in working closely with patient and has establishes a reputed brand in their respective field. Further some investigators have involved in drug development consultation and conducting global clinical studies. Presently more than 200 Investigators have been contracted for clinical research projects execution with IBCR.

Feasibility Process

IBCR has a structured approach to the conduct of feasibility assessments and has a dedicated Global Feasibility Team who follows standardized, validated methods of working to prepare authentic and quality feasibility assessments. Development of the IBCR Investigator Package is based on determination if they have the capability, staff and patients to conduct the study.

The key objectives of the feasibility assessment were to ascertain:

  • Investigator interest in a study in this indication
  • Information regarding patient population and recruitment projections
  • Feedback on study design and eligibility criteria
  • Impact of any competing studies
  • Budget estimates

Quality Management System (QMS)

IBCR is committed to provide quality service in all aspects of the clinical trial. We have a dedicated QA team that is functionally independent and yet forms an integral part of our operations. This independent team consists of experienced professionals and directly reports to the management. The team ensures that the ethical conduct of the clinical study, documentation and reporting of the data in compliance with ICH-GCP guide lines. The documentation is facilitated by methods such as use of checklists and forms, details of action taken, individual’s responsibilities etc. The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data. The verification process is specified and justified.

SOP’s

We have developed all applicable SOP’s pertaining to the CIRMO model. Our SOPs have been whetted by QA professionals in the field. The QA team of IBCR ensures that the staff is trained periodically for the current regulatory guidelines for following the Good Clinical Practices. Staff orientation will also be conducted periodically at the clinical sites with ongoing study, wherein the CIRMO investigators / coordinators are taught theoretical as well as practical skills.

Confidentiality

The business information that you provide to IBCR is considered confidential information by IBCR and we protects this information in several ways. Your personal confidential information resides on a secure server to which only selected IBCR representatives have access, via password.