This is our most preferred business models for naive site, where Incred CR will take care of entire Clinical Operations. Incred CR and the Institution get into an exclusive agreement to have a joint venture to develop the clinical trial set up and to manage the clinical trial operations. Incred CR develops the site by installing the Clinical Trial processes and fulfills the trial requirement of site i.e. Infrastructure and staff. It’s important to note that Incred CR works as a part of the institution rather than a mediator. All exclusive sites of Incred CR will have Clinical Trial Department (as part of the organization) with trained staffs (dedicated for trial activities only) to take care of all requirements of Clinical trial. After the completion of Site Development Program, our Business Development team starts allotting studies to the site.

Brief list of services to an exclusive sites

• Facility and Spacing Plan
• Infrastructure Development
• Formation of Clinical Trials Department
• Staffing for CT Department
• SOP Development and Implementation
• GCP Training Programs and Industry Update Programs
• Site Specific-Business Development
• Management of Clinical Trial Operations
• Co-Ordination with CRO and Sponsors
• Budget Negotiations
• Co-Ordination with Ethics Committee
• Management of Safety Reporting
• Management of Archiving Activities etc

This is the preferred model for sites (Institutions/Hospitals/Clinics) which are already involved in Clinical Research and interested in further development. I5INCRED CR will provide all service as per the requirement to its affiliated sites, this includes but not limited to planning for infrastructure development, consultation for staffing, GCP Training to clinical trial staffs, site specific-business development, etc. On request I5INCRED CR also assigns trained clinical research coordinators in its affiliated sites (study specific).

Affiliated Site Model will help sites to promote their business to next level and to amplify their quality to international standards. Our Service to an Affiliated Site is truly flexible based on the site’s requirement.

This is our Business Model for sites (Institution/Hospitals/Clinics) which requires a foundation in order to conduct Clinical Research. We develop and execute a site specific Clinical Trial Foundation Program and we also assist in building up a Clinical Trial Set-up by providing meticulous trainings to the sites Institutions / Hospitals / Clinics) on various aspects of Clinical Trials. Our Clinical Trial Foundation Program will include but not limited to the following:

• Facility and Spacing Plan
• Infrastructure Development Plan
• Clinical Trials Department Formation Plan
• Training and Qualification requirements for CT Department Staff
• SOP Development and Implementation
• GCP Training
• Training on Clinical Trial Operations
• Training for Clinical Research Coordinators
• Assisting in Ethics Committee Formation
• Training on Safety Reporting
• Training on Archiving Requirements

Through this model we provide our support to sites (Institutions / Hospitals / Clinics) which are already involved in Clinical Research. This model will help Clinical Trial Sites to utilise our expertise to conduct high quality and well-organized Clinical Trials. Our service to sites those who choose our Clinical Trial Support Model includes but not limited to the following:

• Consultation for Clinical Trials Staffing
• GCP Training for CRCs and Investigator
• Quality Audit
• System Audit
• Vendor Audit
• Training on Clinical Trial Operations
• External Audit to Ethics Committee
• Training on Safety Reporting
• Training on Archiving Requirements