CTMG Services for Biotechnology or Pharmaceutical Sponsors
(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 testing of new therapeutic entities as intended in the Sponsor’s FDA-approved protocol. 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 physician investigators 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 payments are accounted and loaded onto their electronic paycard within the week following 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:
CTMG is able to conduct investigative 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 qualifying 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.
In addition to working with multiple Biotechnology Companies who are bringing their first innovative products to clinical trials, CTMG works with multiple large pharmaceutical Sponsors, as well as smaller Sponsors, as these Sponsors realize the value that such process controls provide. We encourage interested Biotechnology and Pharmaceutical Sponsors, and their 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 David Holland, Business Development Associate at: 252-902-6381 or DHolland@CTMGInc.com.