Clinical Development

Our clinical services include:

• Preparation and filing of submissions in Canada and the U.S.:

1. New Drug Submissions and Supplements.
2. Abbreviated New Drug Submissions and Supplements; Investigational New Drug. Submissions (CTA); DINs; Natural Health Product Applications; Medical Devices (Class II-IV).
3. Clinical protocols.
4. Clinical trial reports.
5. Annual reports.
6. Medical monitoring.

• Clinical and technical advice/problem solving/strategy for submissions or responses to Health Canada/FDA/EMEA.
• Liaison with Health Canada and FDA on behalf of foreign and domestic firms.
• Technical report writing.
• Clinical site recruitment.

Clinical development is one of the most crucial and certainly the most expensive part of the product development process. It requires strategic planning in order to maximize the chances of success while keeping the costs at a level that the organization can afford. The characteristics of your product and the market size of the indications for which your product might be suitable are only two of the topics you need to consider when you devise your clinical plan. Logistical challenges (especially with biological drugs), and the preparations sometimes required before administration of your product are additional important parameters to be considered.

By using our contacts in various medical fields we have access to key opinion leaders who can become clinical investigators, in Canada, the U.S. and Israel.

The clinical protocol is the basic document that ensures the proper implementation of the strategic plan. Sometimes, the product requires certain preparation just before administration, or it needs to be administered into a specific location in the body. In such cases thorough training of the clinical investigators is required and one of the tools to help with this training is the study manual. For specific products, such as biologics and especially cell therapies, the logistical challenges related to stability and shipment need to be specifically addressed.

To ensure the consistency of the product’s efficacy and therefore the success of your trial, thorough protocols need to be devised for the preparations required before and after drug administration. These protocols will eliminate the bias and the potential mistakes that the clinical investigators may make. We can combine your intimate knowledge and familiarity with your product with the practical experience that we have gained along the years into a comprehensive and efficient clinical development plan and implement it in the clinical protocol as well as in all the other ancillary protocols.

If needed, we are happy to offer you full service clinical trial management together with one of our associated CROs.