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A well developed and executed Clinical Development Plan should generate the required substantial evidence of a product’s safety and effectiveness in humans. One measure of the success of a clinical program is the speed and efficiency of FDA review of valid scientific evidence leading to either clearance or approval of a marketing application (510(k), PMA). Clearance or approval is dependent on successful and appropriate implementation of a well-designed product and non-clinical and clinical development programs. The Clinical Development Plan is best designed and implemented with the following goal in mind: a successful regulatory submission.

Valiscent can help you formulate your goals, strategies, target population and initial labeling as these will be the building blocks needed to design your clinical trial(s).

There are at least as many definitions of the term Clinical Trial as there are different designs for clinical trials. All of these definitions include some or all of the following elements:

• A planned experiment;
• Assignment of trial subjects to treatment groups;
• Generation of results from a limited number of subjects; and
• Extrapolation of the results to translate the medical risk/benefit ratio to the general population.

Regardless of whether your Clinical Development Plan includes clinical studies, clinical trials, or a combination of both, a well designed study/trial is essential to the generation of valid scientific evidence demonstrating your product's safety and effectiveness in humans.

Using the Clinical Development Plan, Valiscent can help design the clinical trial(s) needed to answer the questions that will eventually support your proposed labeling.

The regulations state clinical investigators must be qualified, as evidenced through training and experience. Hence the selection of the right clinical investigator(s) is not only an important task in the Clinical Development Plan, but it is part of the US Federal Regulations. Unless you have worked with an Investigator previously (typically within the past 2 years), it is expected that a Pre-Study visit be performed to assess the Investigators’ continued ability to perform the study, or if a new investigator, to initially assess their ability to perform in the clinical study.

Through its network, Valiscent can help you develop the plan for identifying potential investigators and eventually qualifying those investigators that will be best suited to conduct your clinical trial.

The Study Initiation Visit is scheduled and conducted only after IRB approval has been received, a copy of the approval letter is provided to the sponsor, and before any subjects have been enrolled into the study. The purpose of a study initiation visit is for the Sponsor and the Principal Investigator with his/her staff to have a detailed discussion about the study procedures, Sponsor expectations and Investigator responsibilities for the study.

Valiscent will assist the sponsor in conducting the Initiation Visit by ensuring the site is prepared from a regulatory perspective while the sponsor ensures the site is prepared from a technical/clinical perspective. It is the final step in a series of preparations that should occur before a clinical study begins.

Monitoring a clinical trial is an important part of a clinical trial success. The regulations state that sponsors must "ensure proper monitoring of the investigation". It is up to the sponsor to develop a monitoring plan consistent with the risk and complexity of the trial. When monitoring a trial the sponsor must not only ensure the data being collected in true and accurate, but must also be monitoring the performance of the investigator and his/her research staff to ensure they are following the written protocol and all applicable regulations, guidelines, institutional polices as well as local laws.

Valiscent can provide trained and experienced clinical monitors to ensure the investigative sites conduct the clinical trial according to the clinical protocol, applicable regulations, state and local laws, as well as Good Clinical Practice.