Study Start-Up Services
Well Begun is Half Done
When it comes to achieving our set study deadlines, getting investigator sites up and running quickly is vital. Integrium’s Regulatory and Contracting teams are dedicated to getting you fast and accurate results and offer continual guidance and support as clinical trials advance through their ongoing stages. Our experts have wide range of experience in handling all aspects of regulations, approvals, contracts, payments, vendor coordination and essential document tracking.
We have an enviable track record that is second-to-none when it comes to dealing with compliance issues and contracts on behalf of our clients. We have easy-to-follow and established processes that ensure that all tasks are started without delay. We can adapt these processes to deal with a large volume of testing sites in a short time while maintaining the highest levels of quality, combined with a speedy service.
Integrium site start-up
Integrium has a dedicated team to help get studies underway and we make sure that they run as smoothly as possible for all parties involved. We have experience in working with a range of investigators and have contacts in establishments ranging from respected academic institutions to private research clinics. Our unique blend of expertise and contacts ensure that Integrium understands the unique and often complex needs of testing sites and personnel. And so that there is no time lost, we offer reviews before start-up so that changes can be proactively implemented.
Integrium’s Contracts group coordinates contracts and agreements with investigator sites and works with our clients to get any necessary approvals. We can handle a large volume of activity and our well-defined processes make us the perfect choice for start-up testing sites. Integrium's clients are continuously updated on the status of sites, contracting and a rundown of how things are going at all stages.
Our Regulatory Compliance group ensures quality control throughout the documentation process, while maintaining flexibility to work within client parameters. We are happy to work with our own templates or those of our customers. In particular, our Regulatory Compliance group manages the submission of several essential documents:
- Form FDA 1572
- Financial disclosures
- Medical licenses
- Protocol signature pages (PSP)
- Informed consent forms (ICF)
- Investigator brochures (IB)/IB acknowledgement forms
- Central Institutional Review Board (IRB) forms
To assure quality throughout these submissions, all materials are serially reviewed. Forms and contracts are also pre-filled for investigators not only for accuracy purposes, but also to reduce the burden on the testing site.
Site maintenance and closeout
While site start-up may represent the bulk of contracting and regulatory documentation, our services also continue for the duration of the study. This ensures Integrium's usual quality and accuracy, while complying with regulatory requirements and keeping projects on time and on budget.