Preclinical CRO & Research Services: Enabling Clinical Trials and Marketing Authorization

With the rising health concerns and the emergence of new biopharmaceutical companies, outsourcing clinical research requirements have become the need of the hour. In such a scenario, it is the Contact Research Organization or CROs that comes to the rescue of these pharmaceutical companies. They help them in speeding up their drug discovery and development process. Thus, they contribute an important role in the life cycle of the pharmaceutical product.

The rising importance of the preclinical research services – 

The preclinical research services or the Contract Research Organizations (CROs) are independently existing companies that render services related to the drug development process. Their principal beneficiaries are biotechnology, pharmacokinetics, and medical device manufacturing companies. Such services include everything right from the selection of the compound to preclinical and clinical research to finished product monitoring and control.

How do the preclinical CROs help in managing the drug development process efficiently?

With their expertise, the CROs are able to handle the drug discovery and related services much more efficiently. Outsourcing the pre-clinical requirements of the pharmaceutical product is a highly cost-effective and reduces in time consumption. Their prime role is testing and evaluation of the drug or the device candidate within a short-time-to-market for their client businesses. This widely covers different aspects of a drug discovery and development process ranging from synthesizing new drug compounds, accomplishing biochemical assays, and conducting preclinical trials using animal models. Additionally, they do focus on clinical trial services related to medical writing, project management, regulatory submissions, data management, and finally, data analysis.

Preclinical CROs as crucial players for the pharmaceutical innovation – 

If you take a keen look at the past decade of the evolution of the pharmaceutical fraternity, the concept of the global pharma industry has changed extensively. The whole sector, including pharmaceutical giants, have been experiencing strict regulatory requirements, cost escalation of commercialization, and patent expirations.

This helps the CROs in delivering the required information, which is a pre-requisite to seek regulatory drug approval. With the increasing requirements for the biomedical and patient data, preclinical CRO are heavily investing in data technology and other artificial intelligence-related services. This has led to continuous speeding up of the entire drug discovery process. Besides, this has also facilitated the collection and analysis of high-quality data which has become the need of the hour. Both the concepts of real-world data and real-world studies are essential here. When the efforts of the clinical research organizations are combined with the expertise of artificial intelligence, big data, and machine learning, the possibilities of improving the overall process of the clinical trials are more.

The current scenario in the preclinical research services has widely evolved with a background of the biomedical information, powerful and efficient technologies, and increasing demand for the interdisciplinary researches. Enhanced complexity of the investigational drugs requires specialised expertise for planning, conducting, and analysing trials.

The preclinical, clinical, and post-approval stages are both complex and regulatory intense stages which require a thorough input from the specialized outsourced preclinical research service providers.