If you would like to learn more about becoming a TMG investigator, please click here to access the Investigator Questionnaire. The completed form can be either e-mailed or printed out and sent in to TMG by fax.  We’ll get back to you as soon as possible to follow up with you personally.  Please take a moment to review the following information to learn more about how TMG supports your clinical research.

Requirements of a Successful Clinical Investigator

• Respect for the significance of delivering quality research data
• Ability & willingness to communicate this approach to all research staff
• Qualified & talented research staff
• Attention to detail
• Standardization of research processes
• Large patient population (2,500 – 4,000+ patients)
• Ability to screen & recruit study subjects
• Active participation of investigator in study
• Careful screening & selection of studies appropriate to practice
• Adequate physical space to dedicate to monitoring visits, storage, etc.
• Adequate research amenities on site (centrifuge, spirometry, ECG, etc.)
• Adequate research amenities off/on site (endoscopy, x-ray, lung function, etc.)
• Investigator/staff commitment to ongoing training/professional development.

The most valuable of the marketing functions TMG undertakes are regular face-to-face meetings with pharmaceutical sponsors to promote the benefits of using TMG for the selection of their clinical investigators.  TMG’s purpose is to make the identification of qualified, experienced investigators the most rapid (TIME), reliable (QUALITY), and cost-effective way (RESULTS) for companies to initiate and carry out their clinical projects.

The value of this is significant. For sponsors to identify qualified sites earlier, to initiate sites into their studies earlier, to meet their patient recruitment targets earlier, and to reduce the amount of time following up on data correction, means all of the resources these activities take are made available for the company’s use elsewhere in the drug development process.

TMG’s purpose is to provide a trustworthy source of experienced, well-managed investigators, to ensure sponsors get the best investigator(s) for their project, and to continually ensure all aspects of the sponsor-investigator relationship are optimized.

A site feasibility questionnaire provides a protocol synopsis followed by anywhere from one to 10 or more pages of site capability questions. Eighty percent of questions are the same for every study (site experience, IRB information, contact info., etc.). TMG completes the 80% for you and provides only the key study-specific questions for your review.  As a result TMG sites can review & complete more feasibilities in shorter time periods, improving your efficiency & allowing you to be a candidate for more studies for which you are interested and capable.

TMG’s success depends on the representation of well-trained, highly professional clinical investigators.  Therefore we can only accept into our network physicians who are committed to ensuring they uphold the highest standards of Good Clinical Practice.

For those investigators, TMG takes responsibility for ensuring they and their staff are trained in the latest regulatory requirements and the most effective tools to implement GCP at their sites.  To complement our training seminars, TMG provides monthly interactive newsletters on GCP topics of interest, website access to study modules, past newsletters, regulatory references, staff training guidance and more.

Health Canada Guide 0068 states, for Qualified Investigators: “Every process should be described in a standard operating procedure (SOP) and evidence of satisfactory training of personnel involved these processes should be documented.” TMG provides all TMG sites with SOPs for their clinical research conduct, updates these SOPs on a regular basis, and ensures that all sites are trained on their proper use.

In support of TMG Site SOPs, the TMG Quality Assurance program can perform QA audits (for compliance with the SOPs) and on-site training and/or mentoring visits to ensure that the reliability of data, and sponsor confidence in the TMG site is consistently superior to that of independent clinics.

Site initiation (study start-up) is a major cause of delays due to incomplete/incorrect completion of forms. For TMG sites, all document packages first come to TMG where they are pre-populated with your site information and presented to you in consistently well-organized packages with clear directions for completion & return.  TMG sites receive one package containing all pertinent study documents ensuring site have a clear understanding of all contractual and study obligations they are being asked to commit to.  Upon return to TMG, document packages undergo an error-check, ensuring any mistakes are caught at TMG and not at the sponsor.

The Clinical Trial/Study Agreement (CTA/CSA) is often glossed-over by investigators, who are too busy to bother reading the pages of legalese, are concerned about being perceived as unreasonable and not being selected for the study, or are trusting that the contract is written to sufficiently accommodate their interests.  However as your legal representative in these agreements, TMG systematically goes through every word in the agreement to ensure your interests and obligations are fairly represented. 

Why is this important? An investigator’s indemnification by the sponsor for claims based on study-related procedures is conditional on the investigator and staff following the protocol and adhering to the CTA. Therefore if the investigator does not understand their obligations throughout the entirety of the CTA, they are putting their indemnification from the sponsor at risk.  The TMG review includes the insertion of template language to ensure the protection of the investigator throughout the CTA, whether in areas of privacy, subject injury, confidentiality, insurance obligations, indemnification, or elsewhere.

The study budget is reviewed and compared with TMG’s database of study procedures drawn from over 200 study budgets, to ensure reasonable fees are being provided for the procedures described. All components of the fees and payment terms are reviewed, and negotiated when feasible.

These worksheets enable study coordinators to ensure that all data required by the Case Report Form (CRF) is collected in its entirety during the course of study visits. They provide a reliable means of transferring source (subject) information from the subject’s medical chart to the CRF by allowing it to be presented in an organized and legible manner.  TMG’s creation of these worksheets contributes to the ease of information management at the site and to the accuracy of the data in the CRFs.

TMG manages any advertising for potential study subjects at all of the TMG sites. This means negotiating advertising budgets, creating ads (newspaper, radio, web), submitting ads for IRB & sponsor approval, paying for the ads & invoicing the sponsor, and following up with sites to determine the success rates of the strategies employed.  There is a TMG subject recruitment website to support all of our advertising efforts that allows potential subjects to learn more about the ongoing studies and to pre-qualify if interested, on their time and in an environment comfortable to them.

TMG tracks the enrolment progress weekly for TMG investigators, for each study that they participate in.  TMG calculates the monies due, based on the procedures performed, and reconciles this data with payments received from sponsors to ensure accuracy and timeliness of all of study payments. When payments are delayed, we are your advocates for timely follow up and keep all TMG sites informed of any expected delay beyond one week of the contract timeline.  TMG can tell any TMG investigator at any time exactly how much is owed to them for each study and when it is due.

Health Canada requires that all records created during the conduct of a clinical trial must be retained for 25 years from the date that they were created.  In order to ensure TMG investigators remain in compliance with this requirement, and to alleviate them from the logistics of identifying and managing these archives under the required storage conditions, TMG is assessing the feasibility of taking on this responsibility on behalf of our investigators.