A clinical investigation is defined as any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a medical device.
The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.
The objective of a clinical investigation is to assess the safety, clinical performance and/or effectiveness of a medical device for a particular indication or intended use.
Clinical investigations are necessary to provide data not available through other sources (such as literature or nonclinical testing) required to demonstrate compliance with the relevant clinical safety, clinical performance and acceptability of benefit/risk associated with its use.
In designing the study, statistical considerations should be prospectively specified and be based on sound scientific principles and methodology. Development of a statistical plan should include consideration of the following:
The design should ensure that the statistical evaluation derived from the investigation reflects a meaningful, clinically significant outcome.
We support you according to your wishes and requirements in the creation of a new clinical evaluation as well as updating your existing clinical evaluation. We can assist with:
All types of clinical studies, i.e., interventional, observational, bioavailability/bioequivalence and post-marketing studies are registered in the CTRI. In addition, it may be noted that clinical studies from traditional medicinal systems as well as clinical studies conducted as part of post-graduate thesis are also registered in the CTRI.
Registration of all regulatory clinical trials is mandatory as per the drug licensing authority in India i.e., the Drugs Controller General (India) (DCGI). In addition, several journal editors, ethics committees and medical colleges have made it mandatory to register clinical studies in the CTRI.
A responsible Registrant, Trialist or User is authorized to register clinical trials in the CTRI. Registration in the CTRI is needed to gain access to this facility. The “Registrant” for a trial is either the principal investigator (PI) or the primary sponsor, to be decided by an agreement between the parties. The primary sponsor is ultimately accountable for ensuring that the trial is properly registered. For multi-center and multi-sponsor trials, it is the lead PI or lead sponsor who should take responsibility for registration.
Biostatistics are the development and application of statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experiments and the interpretation of the results.
Biostatisticians apply deep regulatory knowledge to help you navigate the complexities of study design, including endpoint selection, sample size, analysis methods, and data displays and interpretations, providing speed and flexibility with study reporting.
Biostatisticians collaborate with key groups at every stage during a development program to provide a breadth of services which enhance the overall success.
Clinical investigation is conducted according to a plan (a protocol) or an action plan. The protocol demonstrates the guidelines for conducting the trial. It illustrates what will be made in the study by explaining each essential part of it and how it is carried out. It also describes the eligibility of the participants, the length of the study, the medications and the related tests.
The protocol components are as follows: