Overview
TMG is uniquely poised to design and/or execute trials that address current clinical issues in primary care, impact healthcare policy, and answer questions consistent with your organization’s strategic objectives. Our compact infrastructure allows for a level of responsiveness and flexibility that you won’t find in larger organizations.
Services
TMG provides a variety of services encompassing all aspects of clinical trial conduct:
- Protocol Development
- Site Selection
- Ethics and Regulatory Approvals
- Project Management
- Data Management
- Monitoring
- Medical Writing
- Patient Recruitment and Retention Support
- Vendor Procurement (e.g., statistics, investigational product management)
- Audits
- Training
- Administrative Support
The TMG Difference
The TMG Investigator Network is the largest primary care clinical investigator network in Canada with extensive experience in the conduct of clinical trials. TMG can rapidly select from this network the investigators that are best suited to carry out your studies.
Our in-house team of industry experienced professionals possess the scientific capability and the project management experience to design and conduct high-quality trials. In addition, our investigators have the medical expertise requisite to identify research needs in day-to-day primary practice settings, as well as in certain specialty areas. Working in collaboration, our physician network and scientific team ensure that studies are optimally designed and implemented to address important health care questions.
Experience
Randomised, Open-label, Multi-Centre, Phase IV Study Assessing the Effect of Oseltamivir Treatment on Cognitive Function in Subjects with Confirmed Influenza Virus Infection
Clinical trials.gov Identifier: NCT01249833
Accelerated Study Start-up: 64 days from awarding of project to FPI
Activities included:
- Protocol and consent form finalisation
- Regulatory and ethics document collection
- REB study and site approvals
- Investigator meeting
- Site initiations at 19 sites
- Securing of vendors
- Study branding and awareness campaign
- Patient recruitment and retention plan
- CRF and source worksheet design
- Sign-off on database and validation tests
Effective Project Management
- Managed the collaborative efforts of 5 vendors for efficient study execution:
- Data management
- IVRS
- Online cognitive testing
- Online subject payment system
- Drug and diagnostic kit procurement/labelling/distribution
- Target enrolment achieved
- Extremely high (99.2%) subject retention rate
- Very high (91%) patient compliance with the 14-day self-administered cognitive testing battery
- Manuscript submitted to peer-reviewed medical journal within 4 months of database lock.
Comparison of Time from Symptom Onset to Oseltamivir Access when Oseltamivir is prescribed by Pharmacists vs. Physicians and the Impact on Symptoms, Oseltamivir Resistance, and Patient Safety
Clinical trials.gov Identifier: NCT01456234
Collaboration between primary care physicians and pharmacists
The unique design of this study required the pairing of experienced investigators with pharmacists in close proximity to the investigator’s clinic. Pharmacists were responsible for recruiting patients who presented spontaneously at the pharmacy with symptoms of the flu. After screening by the pharmacist, patients were seen by the investigator, ideally within an hour of their arrival at the pharmacy.
TMG helped establish the communication channel between each pharmacy and its associated clinic to ensure that clinic resources could be made available at short notice when patients presented at the pharmacy.
Engaging pharmacists in clinical research
Very few pharmacists have clinical research experience or the time to engage in studies. Identifying interested and motivated pharmacists located close to investigator clinics was challenging, especially during the busy flu season. Nevertheless, 19 pharmacies paired with clinics were recruited to the study. TMG provided the pharmacists with first-time GCP, Division 5, and other study-related training.