CTMG Services for Sponsor

Identification and Management of Physician Investigator Sites
(Utilizing cGMP-Like Processes Under Layered Quality Systems)
Upon receipt of a detailed synopsis or protocol, CTMG analyzes the operational requirements needed to conduct the study as intended by the Sponsor. Once the likelihood of at least one CTMG site participating is established, protocol specific timelines and processes are developed to clearly define CTMG operational requirements to ensure rapid successful completion of the study. In addition, CTMG determines which of its Business Associate network physicians are interested in the protocol, and determines the precise number of potentially qualifying patients based on the protocol I/E criteria.

Line item budgets and contracts are developed based on CTMG analysis of requirements to successfully complete the study. Upon acceptance of the budget and contract by the Sponsor and PI site, CTMG develops protocol specific Quality Systems and timelines, and upon site initiation, the already identified qualifying patients are called. Conversion of study documentation from human readable format (paper) to digital format with 21 CFR Part 11 validated systems is conducted daily as part of first pass Quality System review. Second pass Quality review is conducted the next day, and the clinical coordinator is notified of any required deficiencies. Prior to and during the study, CTMG’s Regulatory Department ensures proper implementation and documentation of IRB submissions, physician and staff training, Delegation of Authority documents, Safety Report sign off, IRB notification of SAEs and AEs, and site close out.

CTMG’s Accounting and Finance Department utilizes an interactive system with CTMG’s coordinators to ensure patient participation stipend checks are delivered at the end of each visit, not the next visit, to ensure no coercion is utilized to ensure that the patient continues in the study. The Finance and Accounting Department utilizes this same system to check when patient visits are completed to ensure accurate monthly invoicing. Upon receipt of a Sponsor or CRO payment check, this Department also ensures timely payment to the PI sites as per CTMG/Physician contracts. CTMG is responsible for all patient and PI W-9 forms. This comprehensive and interactive Clinical, Regulatory, Contract, Finance, and Quality System management of physician sites has enabled CTMG to have arguably the best clinical site metrics in the nation.

Utilization of the CTMG process results in:

  • removing the need for physician investigator experience as a pre-condition for site success
  • acceleration of site enrollment and the highest patient retention rate in the nation (over nearly five years and hundreds of patients, only three patients have not completed their study for non-protocol related reasons, such as relocating to another area).
  • dramatic reduction in queries, with the fastest identification and resolution times in the industry
  • significant reduction in need for additional clinical sites

    • Clinical Study Feasibility Service
    CTMG is able to conduct physician site feasibility studies utilizing our proprietary operational analysis techniques, current list of physician investigators, and new potential physician investigators. As physician Business Associates, CTMG is able to verify physician numbers, rather than accepting physician estimates of the numbers of patients they have. Our unparalleled Quality and CAPA Systems can be utilized to model new study completion timelines, and give realistic assessments of potential site operational barriers. Electronic enablement currently utilized in CTMG’s core trial management services can also be applied to new study feasibility assessments.

    Nutraceutical Study Management
    CTMG has drafted, evaluated, and managed nutraceutical clinical trial projects for several nutraceutical sponsors. Our systems can effectively be applied to test articles covered by DSHEA legislation, enabling CTMG to take a greater role, if desired by Sponsor, in test article project management.

    Accessing CTMG Services
    CTMG has ‘preferred provider’ status with several top ten pharmaceutical Sponsors, as well as smaller Sponsors, as they realize the value that such process controls provide. We encourage interested Sponsors and CROs to visit CTMG, and arrange for an audit of our systems. If you would like more information, or would like to schedule a visit, contact Laura Thompson, Business Development Manager at: 252-902-6381 or LThompson@CTMGInc.com.