Clinical trials begin with:
- Physician has an interest in researching a new compound
- Physician is contacted by Medicor about a new clinical trial
- Physician is contacted by a pharmaceutical company about a new trial
- Medicor sources a pharmaceutical sponsor and clinical trial for the physician or Medicor contacts a physician about a new clinical trial or
- The physician forwards new clinical trial information to Medicor
- A pharmaceutical sponsor provided confidentiality agreement is signed by the physician and submitted by Medicor
- The protocol is sent to Medicor and the physician for review
- A sponsor provided feasibility questionnaire is completed by Medicor with the physician
- The sponsor assesses the feasibility questionnaire to determine suitability of the research site
- If the sponsor determines the site is suitable for the clinical trial they conduct a pre-site visit with Medicor and the physician. The purpose of the visit is to view the facilities where patients will be seen, to ensure the site processes and procedures meet the standards required by the clinical trial, equipment used for the clinical trial is calibrated and in good working order, and to discuss patient recruitment capabilities. The pre-site visit is also an opportunity for the physician to get questions about the protocol answered and determine if he wants to conduct the clinical trial. After the pre-site visit a report is sent from the sponsor to the physician and Medicor, followed by a letter of acceptance or rejection of the research site.
- Upon acceptance of the clinical trial Medicor requests the study start-up documents, completes the regulatory and ethics submissions on behalf of the physician. The physician signs the required documents and they are submitted by Medicor. The sponsor’s contract and opening budget offer are reviewed by Medicor. A cost analysis is completed and the proposed counter budget offer is presented by Medicor to the physician for approval. Medicor then negotiates and finalizes the budget and the contract is then signed by Medicor and the physician. Medicor and the physician sign a “Letter of Understanding” which contractually links sponsor -Medicor-physician.
- Medicor staff and the physician attend the Investigator Meeting or teleconference which begins the training and orientation to the clinical trial. Medicor staff set up the physician’s office as a research site providing equipment and supplies required by the clinical trial. Trial worksheets (source documents) and study logs are created by Medicor. Required third party providers for diagnostics, supplies and advertising are contracted by Medicor. Medicor staff and the physician complete on-line training.
- Once all regulatory and ethics approvals have been received and Health Canada has provided a “No Objection Letter” the sponsor conducts a “Site Initiation Visit” with the Medicor staff and the physician. Study drug is received. The sponsor gives Medicor and the physician the green light to begin seeing patients for the study.
Medicor starts recruiting patients for the study and screening visits are booked at the research site.
The physician delegates the following to the Medicor staff:
- Informed consent
- Medical and medication history collection
- Diagnostic procedures EG: blood draws, ECGs, spirometry, vitals
- Management of the investigational drug IE administration, dispensing, re-stocking, temperature monitoring, accountability logs, destruction
- Data entry through electronic data capture systems
- Booking diagnostics to third party providers
- Retrieving patient records as applicable
- Scheduling patient follow-up visits
- Adverse event and serious adverse event documentation
- Facilitating sponsor monitoring visits
- Data query resolution
- Invoicing, reconciling sponsor payments, patient stipends, paying third parties
- 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 to the study
- Physical and/or psychological assessments required by a qualified physician
- Causality of an adverse or serious adverse event
- Medication and investigational drug orders including prescribing, titration, interruption and discontinuation
- Un-blinding a patient from a blinded investigational drug or treatment
Financial management of the study; invoicing, accounts receivable, and accounts payable