Pharma costs are the growing components of health care costing today. Pharma R&D is a process discovering, developing and bringing to market novel drug products and is a significant cost contributor. Clinical research, an important sub-process in pharma R&D, ensures quicker returns on investments made for the pharma company and drives access to a better patient care.
Pharma R&D has 2 objectives: novel drugs and new markets But, pharma companies today are under economic and regulatory pressure than before. On the other hand, IT is driving a greater adoption of evidence-based platforms for information management and dissemination.
A few trends in clinical research discussed here say that the industry is searching for opportunities to enhance efficiencies of their processes of product development for quality delivery.
Clinical research outsourced
The costs of drug development rose up in the past decade, forcing pharma companies to look for innovations and smarter ways of doing business. One of the major in trends that have come up from high costs is companies outsourcing their clinical trials. By outsourcing, pharma companies reshape the drug development services industry. They have grown from just a few companies providing limited clinical trial services to big MNCs providing various services like preclinical assessments, study design, clinical trial plans and management, data monitoring, bio-stat analysts and many more. CROs have been providing preclinical and clinical trial services, but they are broadening their expansion into project management.
Electronic records made research easier
Another way to reduce cost pressures is to shift clinical trials to lower cost areas. Globalizing clinical research provides CROs with an opportunity to run clinical trials efficiently and at a lower cost.
The outsourcing market has evolved into 2 segments large sponsors that emphasise partnerships and functional outsourcing, with in-house PMs and small sponsors opt for turn-key solutions.
Adoption of electronic records
Another trend that is fast evolving is to go paperless and increase in the acceptance of electronic records. A novel drug application has hundreds and thousands of paper records. Adopting electronic records has made searching and analysis easier and also improved efficiencies of other initiatives to lower the costs of development and data management in clinical trials. These are several technologies that support the electronic data capturing and also the clinical trial management systems for information on administration.
But, in comparison to changes in the ways of clinical process teams and the developments in web based communications tools, the progress towards a complete paperless clinical trials is very slow. Experts say that the attempt is to adept EDC for all new trials and selectively digitize the ones done in the past is also required. Going the e-way permits for better collaboration across various stakeholders in the clinical trials processes.
Enabling an integrated clinical enterprise
One of biggest challenges of life sciences industry is to face the need of integrating the information that exists from discovery through clinical development and commercialization. The next trend relates to integrating the collected data, data management, data repository and safety data under one roof along with giving a new definition to the business processes and technologies within an organization. Several large pharma companies have their own initiatives in this sector.
The processes of such initiatives are around defining standards for clinical data. It might take years to complete the implementation of such initiative. There is a due consideration of the need to put together domain and technology skills and achieve the benefits by the pharma company and the world at large would be significant considering the impact this would have on bringing the drug to the marked safety, quickly and cost effectively.
These emerging trends in clinical process indicates a shift from efficiency centric approach to a broad based effectiveness oriented approach.
We conclude the discussion here. Hope you liked it and let us know what else could be the advantages of technology in the field of clinical research trials.
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