Our Research Team Provides:
- Rapid, cost-effective study initiation.
- A multi-faceted approach to investigator selection that draws on iProcess Investigator Match proprietary investigator database to find the right investigators for your study.
- Essential Document Maintenance – A dedicated staff coordinates the collection, review, and tracking of essential documents. This assures that the trial master files are kept current. The team also handles the distribution of study-related materials to the sites.
- Clinical Trial Agreement Execution – Experienced staff to manage contract and budget negotiations.
- Investigator Payments – The contracts management staff work closely with the project managers to facilitate timely, accurate payments to investigators and institutions.
Strong project management is an essential part of running a successful trial. As the primary point person, the PM is responsible for overseeing all client/CRO interactions, managing study sites, coordinating investigator payments, monitoring study metrics, training, assuring adherence to timelines, and coordinating interactions among iProcess’s operations teams. iProcess has a unique site management model in that the PM is responsible for site management of the study. This model ensures that a knowledgeable person is always available for answering site queries regarding eligibility questions or evaluation issues, and also assures consistency of response across sites.
Accurate, timely, and proactive communication is key to a study’s success.
To this end, PMs initiate and/or oversee:
- Regular team teleconferences
- Project oversight meetings
- Provision of GCP compliance input
- Telephone contact with sites
- Production of newsletters
- Tracking and updating of regulatory documentation
- Distribution and tracking of IND safety reports
Our PMs produce regular written project management status reports. In addition, clients have 24/7 access to real-time study data through a customized website, which allows them to view investigator site reports, enrollment reports, safety status reports, and data metrics reports.
Clinical monitoring activities include:
- Site identification
- Site qualification and initiation
- Regulatory document collection
- Investigator meeting planning and presentation
- Site personnel training
- Interim site monitoring
- Site termination
- Contract negotiations
- Submission for Institutional Review Board or Independent Ethics Committee (IRB/IEC) approval
- Patient Follow-up
- Informed consent form (ICF)translation into vernacular languages
- Site initiaton and trial close-out operations
- Trial-related documents archival and maintenance
- Reporting serious adverse events to the CRO and the IRB/IEC
- Ensuring protocol compliance
- Advising & alerting investigators of potential ICH-GCP violations