Controlled Processes, Enabling Superior Performance.

CTMG employs a highly integrated and controlled process to support the execution of clinical trials by Principal Investigators. CTMG augments the Physician’s medical expertise with additional staff and systems necessary for successful trial completion in the areas of contract negotiations, financial oversight, regulatory requirements, and clinical execution.

Investigators can expect the CTMG staff to be fully aware of study protocol requirements and to integrate with their office practice seamlessly. Likewise, we continuously survey our business associate physicians to assess satisfaction and solicit suggestions for improvement.

The Clinical Trial Problem

Nationwide, over 70% of physician investigator sites are non-performing in conducting Pharmaceutical clinical trials, resulting in excessive costs, delay to FDA submission, delayed time to market, and an increasing number of drugs pulled from the market. All Pharmaceutical Company Sponsors (PCS) and their Contract Research Organizations (CROs) utilize similar site selection and management tools, yet poor site metrics persist. The result has been fewer drugs in clinical development and large pharma downsizing from not realizing projected financial expectations.

Neither Sponsor Pharmaceutical Companies, nor their partnering CROs can operationally manage the physician offices and physician personnel (or provide alternative personnel) because of conflict of interest issues. While some CROs have tried to set up firewalls and assign CRCs to physician offices, they have perennially failed as the systems to ensure operational efficiencies are not known to clinical personnel (either CRCs or Physician Staff), and hence are not in place to improve site performance.

Currently, all aspects of new drug development are done under tightly controlled, planned, and documented processes (cGxP and Quality Review), except the final area of research involving human patients. CTMG has demonstrated that by applying the proven cGMP-like processes under required Quality System control (that result in predictable transition from discovery and pre-clinical phases of development to clinical human studies), the risk of under- or non-productive physician sites is greatly reduced.


The CTMG Solution

The CTMG solution applies the same cGMP-like processes under QA/QC controls, for the first time to physician sites. As business associates, CTMG manages clinical trials in large physician sites, regardless of physician experience, under such controlled systems, utilizing our proprietary approach. Many of our top enrolling sites have never done a clinical study before, but because CTMG’s systems focus the physician on the medical aspects of the study (while we handle the operational implementation under industry cGMP-like processes and Quality Systems) prior clinical trial experience is not required. These systems reduce the risk of site non-performance, and CTMG managed sites are 78% effective in meeting or exceeding sponsor contract goals, on or ahead of schedule, regardless of physician trial experience.

Trained CTMG personnel (with documentation not only of training, but of proficiency) manage large physician practices utilizing a comprehensive process control system, with redundant quality system controls. Increased efficiency results from CTMG’s operational and Corrective and Preventive Action (CAPA) systems, resulting in rapid identification of any trial operational barriers, with equally rapid site adjustments made. A recent analysis demonstrated that 76.9% of Trial Naïve Investigators achieved or exceeded their contracted patient numbers with their first trial utilizing CTMG (with 30.5% of these Naïve Investigators being the #1 or #2 site with their first study, utilizing CTMG). This compares to 72.4% of Experienced Investigators achieving or exceeding their contracted patient number utilizing CTMG for the first time. CTMG provides 24/7 remote access to study data through encrypted tunnels into secure servers, enabling real time Sponsor access to site performance. CTMG is the only group that converts all completed paper documents to non-editable digital format for remote access viewing under 21 CFR Part 11 compliance.

Enables Sponsor/CRO monitors to quickly and remotely review the progress of CTMG managed sites, with access to all original medical data, within hoursof the patient visit. Several Sponsors exclusively utilize CTMG sites as their first initiative sites, as they can efficiently determine any operational barriers to completing protocol requirements in conjunction with CTMG’s powerful CAPA systems. Now in its 5th year, CTMG has conducted over 50 site trials, and is soon to expand from its Regional NC Physician Network to partner with interested physician sites in Ohio, Maryland, Virginia, and Kentucky utilizing our electronic systems for management control.


CTMG Services

  • Identification and Management of Physician Investigator Sites
    (utilizing cGMP-like processes under Layered Quality Systems)

    Upon receipt of detailed synopsis or protocol, CTMG analyzes operational requirements to conduct study as intended by Sponsor. Once likelihood of at least one CTMG site will participate is established, protocol specific timelines and processes are developed to clearly define CTMG operational requirements to ensure rapid successful completion of study. Line item budget and contracts are developed based on CTMG analysis of requirements to successfully complete study. Upon acceptance of budget and contract by Sponsor and PI site, CTMG develops protocol specific Quality Systems and timelines. Conversion of human readable format (paper) to digital format with 21 CFR Part 11 validated systems is conducted daily with first pass quality system review. Second pass quality review is conducted the next day, with the clinical coordinator notified of any required deficiencies. As is the case 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 have the patient continue 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 the 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 numbers, with 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 moving).

    ◊ dramatic reduction in queries, with the fastest identification and resolution times in the industry

    ◊ dramatic 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, not take physician estimates of the numbers of patients they actually 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 service can 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, check our contact information.