Study Management

Project management and clinical (on- and off-site) monitoring of clinical studies

Oncology trials are complex. All of our project managers and CRAs have deep hands-on oncology clinical trials study management experience. Knowing the sites, patients and investigators allows us to comfortably manage the risks and opportunities that occur during a Phase I, II or III oncology clinical trial.

Careful management of site visit frequency and time on-site can be very critical to the economics of a study, but this factor has to be balanced at all times to assure the accuracy and completeness of data.

Medical monitoring and management, safety reporting, SAE narratives

Medelis also provides drug-safety services to manage the collection and reporting of serious adverse events. We can define the overall procedures for the collection, evaluation, and reporting of SAEs, providing 24 hour assistance and immediate reporting from site to you.

Board-certified clinical oncology specialists are also available to offer medical management and oversight on a client’s behalf, working closely with site investigators and the client’s own experts to assure the greatest safety for patients.

Document preparation and production

Medelis can assist in creating, reviewing and approving all clinical trial documentation, from site-specific informed consent documents to all original regulatory documentation, including:

• Signed and dated protocol signature page
• Completed Form FDA 1572
• Current curriculum vitae of the principal investigator (within 2 years or initialed & dated within 2 years)
• Copy of current medical license for the principal investigator
• IRB approval letter of the protocol and informed consent form
• Current IRB membership roster (within 1 year)
• Financial disclosure form
• Notification or approval of regulatory agencies
• Signed and dated confidential disclosure agreement
• Investigator Agreement (contract/budget) completed and signed
• Completed IRS form W-9