Clinical studies are sometimes called Clinical  trials and typically involve humans. During a study or several studies, researchers assess the effectiveness of health products. The test products include medicines, devices, diagnostic products and sometimes natural health products. Health products are intended to be used in the prevention, treatment, diagnosis or prevention of a disease. Clinical studies involve different groups of people or even organizations. All these groups need adequate training to accomplish their goals. We will consider the following briefly.
•    Clinical investigators
•    Sponsors
•    Clinical monitors or Clinical Research Associates
•    Research Ethics Committees
•    Clinical Research Organizations
•    Regulatory Affairs Clinical investigators
An investigator wth a Clinical studies participant

Clinical studies participant and investigator

Clinical investigators and Clinical studies

All clinical studies must have a Clinical investigator. In Canada the clinical investigator responsible for a site is called a qualified investigator.  The qualified investigator is supported by other investigators such as sub-investigators.  Qualified Investigator is  responsible to the sponsor for the conduct of the clinical trial at the clinical trial site. The QI is required  to provide health care to the study participants under the laws of the province where that clinical trial site is located. This responsibility cannot be delegated.

Sponsors and Clinical Studies

The sponsor in clinical studies could be an individual, a corporation, institution or organization that normally conducts clinical trials based on government regulations. The sponsor must comply all the regulations depending on the jurisdiction. The sponsor should all adhere to the good clinical practices.

Clinical monitors or Clinical Research Associates

These are well trained individuals who work under the guidance of the sponsor to ensure that clinical trials are conducted according to the protocol. They also ensure that the monitor has the right resources to carry out the clinical trials . They provide reports to the sponsor about the clinical trials.

Contract research organizations

Contract research organization refers to a person or an organization that assumes some or all the responsibilities of the sponsor.  The Contract research organization may design a protocol, handle the selection or monitoring of investigations, evaluate reports, and prepare materials to be submitted to regulatory agencies.

Independent Research Ethics Committee

This is a review panel to ensures the protection of the rights, safety, and well-being of human subjects who have volunteered to participate in clinical trials. The committee should be constituted according to the regulations. It also provides assurance to the participants that their welfare is protected.

Regulatory Affairs and Clinical Studies

Regulatory affairs personnel help sponsors to file dossiers to regulatory agencies such FDA and health Canada. Sometimes a lot of time is wasted before a clinical trial can start.
We will help you to prepare your CTA or IND either on paper or using the electronic format. If you don’t have all the required information we will walk you through the process of acquiring the information. We will arrange for meetings with Health Canada or FDA if you need it.
Some of the things clients ask for include:
1.    Assembly of forms and letters
2.    Approval of your protocol and informed consent by a qualified REB
3.    background information
4.    Preparation of  different modules
5.    Review of safety and quality information
6.    Prepare an amendment
7.    We will customize your package depending on your needs.

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