Whether you are new to clinical research or are an experienced investigator, TMG will take your research operations to the next level.

New to Clinical Research?

Are you interested in clinical research, but are unsure of the commitment it will take or how to get involved? As a busy physician, will you be able to find the time and resources to make it worthwhile? How difficult is it to get started? This is where TMG can help. We provide the support you need to become a successful clinical investigator. Start with our “Requirements of a Successful Clinical Investigator” guide below, then contact us to set up a call with our President, John Akitt.

Looking to become a successful clinical investigator? Please contact us and we will follow up personally.

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For Experienced Investigators

How do you continue to grow your business? By increasing the number of studies at your site; by enrolling more subjects in each study; and by earning more revenue per subject. Decreasing administrative costs would be nice, too. Who is helping you to do this? Is your research business at the stage where it’s time to take it to the next level, by joining the professionals at TMG? We’ve been making the best research sites better for 25 years.

  • Whether your ambition is to start >10 new studies or to excel in 3-5 every year, being a TMG investigator means you have a full-time business development team that is constantly procuring study leads for your business.
  • For high-performing sites who regularly meet or exceed their enrollment targets, increasing enrollment by even 2-3 subjects per trial has huge value. That’s why TMG supplements our investigators’ eligible pool of research volunteers with our database of over 8500 pre-screened patients, who are a primed audience for invitations to ongoing studies at TMG sites.
  • TMG increases your revenue/subject by ensuring all revenue gaps are sealed: invoiceable items, unscheduled visits, archiving costs, etc. are negotiated, billed, tracked, and reconciled for you as part of our comprehensive financial management services.
  • Get your most valuable asset, your research staff, spending their time on value-added work like screening subjects and documenting trial data. Give TMG the easily-centralized work like training new study personnel, keeping your SOPs up to date, creating source worksheets, and submitting and following up on your study feasibility questionnaires.

TMG makes sure you have peace of mind about your research business; that your risks are fully understood and mitigated, and that your revenue opportunities are fully realized. From hazardous goods training to ACRP accreditation to professional liability coverage to off-site, 25-year archiving, TMG has the resources to take your research business to the next level.

If you are an experienced investigator practicing in Canada and would like to learn more about becoming a TMG investigator, please contact us and we will follow up personally.

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TMG Investigator Services

Please take a moment to review the information below to learn more about how TMG supports our investigators and what it takes to be a clinical study investigator.

1. Marketing of Investigator Network

The most valuable marketing function TMG undertakes for its investigators is regular face-to-face meetings with pharmaceutical and medical device sponsors, promoting the benefits of using TMG for selection of clinical investigators. Our goal is to show study sponsors that our investigators provide the most rapid (TIME), reliable (QUALITY), and cost-effective (RESULTS) way for companies to initiate and carry out their clinical projects.

The value of this marketing service to our investigators, especially our new investigators, is significant. The relationship that TMG has developed with pharmaceutical and medical device sponsors over the years means that you do not have to spend time looking for studies. Study sponsors come to us – and then we bring their study opportunities to you.

When TMG is approached with a new study, the sponsor provides us with a study synopsis and a site feasibility questionnaire. This questionnaire may include anywhere from one to 10 or more pages of site capability questions. The answers to eighty percent of these questions are the same for every study (e.g., the site’s research experience, contact information, ethics committee requirements), but must be completed for each study often using different formats. TMG completes the 80% for you so that you can focus your valuable time on answering key study-specific questions regarding your practice. As a result, you can complete feasibility questionnaires in a shorter time, submitting them sooner and improving your chances of being chosen for a study.

Good Clinical Practice (GCP) guidelines and Health Canada regulations require that investigational sites have SOPs. The writing of clinical research SOPs that will pass regulatory inspection requires in-depth clinical research experience and can be a very time consuming process.

Recognizing these challenges, TMG provides all of its investigators with a set of clinical research SOPs. TMG updates these SOPs on a regular basis, and offers ongoing SOP training to all of its sites. TMG also assists sites with supplementing the TMG SOPs with site-specific information. Having a common set of SOPs that apply to all TMG sites is a selling feature for sponsors – they know that the same high quality can be expected from all TMG sites.

The safety of study participants and the integrity of study data is of utmost importance to TMG and our investigator network. Therefore, we accept into our network only those physicians who are committed to upholding the highest research standards encompassed in Good Clinical Practice (GCP) guidelines and applicable Canadian regulations. In return, TMG takes responsibility for ensuring our investigators and their staff are trained in the latest regulatory requirements and have the most effective tools for implementing GCP at their sites. To complement our training seminars, TMG provides monthly interactive newsletters that include GCP topics of interest and quizzes. We also provide website access to our newsletter archives, training modules, links to regulatory and other applicable references – and more.

To help ensure that our sites are adhering to SOPs, GCP and applicable regulations, TMG conducts quality visits and provides customized on-site training and mentoring in response to any observations. TMG also helps our sites to prepare for regulatory inspections. TMG’s quality program inspires sponsor confidence that a TMG site is consistently superior to independent clinics that are without this type of quality support.

Completion of the reams of documentation required to start a study is a very time-consuming process for all investigators, and can be rather overwhelming for new ones. Start-up delays are common in clinical research, and are often due to incomplete/incorrect completion of forms. TMG assists its sites with timely and accurate completion of forms by pre-populating the documents with as much information as we can. The documents are then presented to you in a consistently well-organized package with clear directions on which sections require your completion. Upon return to TMG, the document packages undergo an error-check, ensuring any mistakes are caught at TMG and corrected before the documents are sent to the sponsor. This service ensures your site consistently makes the right impression on sponsors and can help you to get your studies up and running more quickly – giving you a recruitment advantage over sites without this type of assistance.

Every study comes with a study contract referred to as a Clinical Trial/Study Agreement (CTA/CSA).  This contract is often glossed-over by investigators, who may be too busy to read page after page of legalese; who may be concerned about being perceived as unreasonable in their demands, lessening their changes of being selected for the study; or who are trusting that the contract is written to sufficiently address their interests. Don’t leave review of the contractual details of your studies to chance. As your legal representative in these agreements, TMG is there to protect you – systematically going through every word in the contract to ensure your interests and obligations are fairly represented.

Another important component of contract review is assessing the suitability of the budget.  The budget should reflect costs for all of the procedures that the investigator and study staff will undertake during the study. Over the years, TMG has built a database that lists fees for study procedures drawn from over 500 study budgets. Equipped with this information and our negotiating experience, TMG ensures that our investigators are fairly compensated for the work they perform. All aspects of the fees and payment terms are reviewed and negotiated as appropriate.

The complexity and volume of information that investigators and their staff must record during study visits can be massive. In addition to collecting data that sponsors will analyse to answer the study objectives, investigators must ensure there is documentation to prove that all study procedures were conducted according to the protocol. In order to meet these demands, most research sites design worksheets for each of their studies. Designing high-quality worksheets is very detailed and time consuming work – work that TMG performs for its sites. TMG’s worksheets help guide our sites through each study visit, ensuring that procedures are performed in the proper order; that the appropriate data is collected; and that the study is conducted in accordance with GCP. By providing worksheets to our sites, TMG frees up its investigators and coordinators to focus on what only they can do – provide care to their study subjects.

Recruitment of patients meeting the eligibility criteria for studies remains one of the biggest challenges in clinical research. TMG assists its investigators in their recruitment efforts by: negotiating advertising budgets with sponsors; creating ads (newspaper, radio, web); submitting ads for ethics and sponsor approval; arranging for placement of ads including payment management and invoicing of the sponsor; and following up with sites to determine the success rates of the strategies employed. Sites do not have to spend their valuable time working on the details of ad design, approval, and placement in order to take advantage of the recruitment opportunity that advertising presents.

Recruiting patients is about more than screening medical charts. It’s also about creating awareness in your community about opportunities for clinical research participation and the importance it plays in the advancement of medicine. TMG is your active partner in this effort through site branding initiatives and digital marketing, centred around our investigator network research website, called JoinAStudy.ca. All ongoing studies at TMG research sites are listed here, offering prospective study subjects the ability to: find out what research is available in their area; learn more about each trial; and register online if they’re interested in being involved. Each TMG network researcher is professionally profiled on the site so that prospective volunteers can become familiar with your site and staff prior to registering.

But Joinastudy.ca is more than just a trial and site listing portal. It is also a reliable and medically-reviewed source of general health information that potential study volunteers can trust, and that they can comfortably bookmark and return to regularly. Joinastudy.ca is further supported by the JoinAStudy Facebook page and JoinAStudy Twitter account, where health information and research news items are posted regularly.

One of the most frustrating and challenging things about being a clinical researcher is making sure you are getting paid, and paid accurately, for not only the study visits but also for the trial-specific invoice-able items that are in the budget. Ensuring the accuracy and timeliness of all your study payments is a service that TMG provides to its investigators. We track all of your subject visits and reconcile this data with payments received from sponsors. We know when payments are delayed, and are your advocates for timely follow up. To be really effective at this, TMG and your staff have to work closely together, to ensure that site staff know when to recognize invoice-able patient visits/items and to notify TMG so that we can invoice the sponsor. We know how easy it is for these to be overlooked, and how important these are in contributing to your bottom line.

Requirements of a Successful Clinical Investigator

  • Respect for the requirements associated with delivering quality research data
  • Commitment to protecting the rights and safety of study subjects above all
  • Ability & willingness to communicate the above 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 overseeing the study
  • Careful screening & selection of studies appropriate to practice
  • Adequate physical space to dedicate to monitoring visits, study supply 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

TMG is seeking Canadian physicians to join our clinical investigator network.  Whether you are new to clinical research or an experienced investigator, please contact us for more information.

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