Understanding clinical research
Ensuring safety and efficacy of healthcare products
A healthcare product meant either to respond to a malady in terms of treatment, relief or prevention of the same, especially if meant to be ingested, must be safe and of acceptable efficacy. This is achieved through clinical research. Clinical research procedures are developed by healthcare experts with the requisite domain knowledge to best evaluate a given product for its stated purpose before its introduction in the market.
Regulatory analysis and approval
These procedures are further analyzed by regulatory bodies across the globe before being accepted. These procedures then become the basis of clinical research program from which tomes of healthcare data is obtained. The data goes to a regulatory consultant who judges it based on quality and may recommend changes if they are under the impression that the standards of a given regulatory body are not met.
Role of clinical research consultants
Clinical research consulting firms require highly credentialed professionals to be conducted reliably. Clinical research consultants assist such programs in their goal of developing and marketing the product effectively in a manner agreeable to regulators. The scope of their responsibilities is broad and includes the determination of product safety profile or monitoring the efficacy of a candidate medication or method of treatment. They can move quickly to help an overtaxed sponsor send the clinical data to authorities for review.
Addressing risks and precautionary measures
Sometimes, a critical medicine may pose risks of side effects or may be unfit for the consumption of people of a certain age (children below 14 years) or in a certain physical state (pregnancy). In such cases, precautionary labeling will be necessary. In general, precise, informative labeling is necessary for any medical product. Clinical research consultants evaluate the health data insights to influence the labeling of a product by guiding the company to structure the information correctly across the different labels on it.
The role of CROs (Clinical Research Organizations)
CRCs work in association with CROs and CRAs to conduct and monitor clinical trials regularly. It is important to look at what CROs do. They are enormously important for pharmaceutical, biotechnological industries and medical device manufacturers. They outsource research services in the form of domain expertise and methodological expertise on contract to medical companies.
CROs aid the development of new drugs, designing the trial as per regulatory requirements and administering the process from the pre-clinical phase to the early phase clinical trials. Their responsibilities include:
- Selecting the right site for a trial
- Choosing the right patients for trial and obtaining their consent
- Collecting trial data for evaluation
- Ensuring that the trial process remains safe throughout for all involved
- Verifying that the drugs are safe before being introduced to the market
The analysis of health data for insights
The clinical research consultants must analyze the data in an unbiased manner and preserve its integrity. It is also responsible for collecting and reviewing the data in a timely manner. Healthcare data can be analyzed by an analyst using data analytics tools to find patterns and trends in the given data set. Insights can then be drawn from them to achieve better patient care, improve healthcare processes and get a sense of the efficacy, safety or both of a drug under trial.