Because rapid investigator site activation is paramount to achieving study timelines, Integrium’s Regulatory and Contracting teams are dedicated to swift and accurate study initiation activities, and continual diligence in advancing clinical trials through their various stages. Our staff can handle all regulatory approvals, contracts, payments, vendor coordination and essential document tracking.

Integrium’s depth of experience performing regulatory compliance and contracting services on behalf of our clients has provided established processes to complete start-up tasks thoroughly and without delay. Even when dealing with a large volume of sites within a short period of time, Integrium maintains a reputation for both speed and quality.

Site startup

Integrium has a dedicated team to initiate studies. Our overall objective is to expedite the process by making it as easy as possible for all parties involved. We have extensive experience working with a range of investigator sites, from academic institutions to private research clinics. This history means we understand the nuances of starting up each type of site. We utilize proven workflows to navigate these complexities, starting with contract review up front so that we can proactively implement changes without sacrificing startup time.

Integrium’s Contracts group coordinates the execution of agreements with investigator sites and works with our clients for necessary approvals. We have the capability to handle a large volume of contracting activity and well-defined processes to support this critical start-up activity. Clients are continuously updated on the status of site contracting, with a focus on initiating all sites as expeditiously as possible.

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 site.

Site maintenance and closeout

While site startup may represent the bulk of contracting and regulatory documentation, our services also span across the entire duration of the study — always ensuring quality and accuracy while complying with regulatory requirements and keeping projects on time and on budget. Regulatory Compliance continues to proactively process and produce all essential documents through study closeout.