The physician has an idea for a research study and contacts Medicor
- The physician discusses a research study idea with Medicor
- Together the physician and Medicor determine the feasibility of the study
- Medicor works with the physician to develop a research study protocol
- Medicor develops a statistical analysis plan with the biostatistician and the physician
- Medicor sources equipment, supplies, diagnostics, third party providers, etc
- Medicor develops a budget for the project
- Medicor completes and submits a grant application for the project
- Upon grant approval Medicor prepares the study for ethics board review and the physician presents the study to the ethics board if applicable.
- Medicor staff set up the physician’s office as a research site providing equipment and supplies required by the research study. Trial worksheets (source documents) and study logs are created by Medicor. Medicor puts in place the data collection systems. Required third party providers for diagnostics, supplies and advertising are contracted by Medicor.
For studies involving patients, Medicor starts recruiting patients for the study and screening visits are booked at the research site. The physician delegates the following applicable tasks to the Medicor staff:
- Informed consent
- Medical and medication history collection
- Diagnostic procedures EG: blood draws, ECGs, spirometry, vitals
- Transmission of data through electronic data capture systems
- Booking diagnostics to third party providers
- Scheduling patient follow-up visits
- Adverse event and serious adverse event documentation
- Study closeout procedures and archiving
The physician cannot delegate the following activities:
- Determining patient eligibility to participate in the study
- Interpretation of diagnostic results and deeming them to be clinically or not clinically significant
- Physical and/or psychological assessments required by a qualified physician
- Causality of an adverse or serious adverse event
- For studies not involving patients, Medicor staff will collect and submit data for statistical review.
Medicor oversees quality assurance of the collected data and submits to the biostatistician.
Upon request of the physician Medicor will assist with any or all of the following:
- select an appropriate outlet for publication
- preparation of the research manuscript; working within the aims and scope of the target journal(s)
- arrange a third party copy-edit of the title, abstract and manuscript
- submit for peer review
- address the reviewers comments and make necessary changes