Technology is the backbone of successful companies and pharmaceutical, medical and biotech industries are no exceptions. Using the right technical expertise could be the differentiator that elevates a particular company, by making it more efficient in achieving its goals.
The main aim for organizations that manufacture devices for these industries is that the products reach the end customer successfully. This is no easy task with clinical trials, regulatory requirements and many other complex steps along the way. It is essential to find the right technology partner to provide Contract Research Organization (CRO) services to overcome these challenges. Here are some of the ways in which a vendor should be able to support you with their CRO solution:
Adapting to Regulatory Changes
Ensure that the partner you choose has an in-depth understanding of the regulatory processes including how to apply for new clinical trials, and details regarding import and export licenses. Since these regulations change often, it is also essential that the vendor is aware of all the important transitions.
Project and Site Management
Managing resources for the project and the site is an important requirement for the trial to function as planned, but this takes away precious time from research and medical work. Choosing a seasoned CRO solution provider like HCL Tech assures you that tasks like client interfaces, supply chain management, routine site monitoring and risk-based monitoring are taken care of.
Medical Monitoring and Safety Surveillance
The team that is in charge of the medical monitoring would have therapeutic expertise, and would use tools such as questionnaires to help in the process. This means that medical reviews and monitoring as well as periodic review of the lab data to ascertain safety are taken care of by the CRO solution provider through process management tools. The monitors are also responsible for consent forms and collection and analysis of all data related to safety such as Drug Safety Update Reports (DSUR) and Periodic Adverse Drug Experience Reports (PADER).
When you choose an experienced CRO partner, it would offer you a team of expert medical writers with relevant writing experience. This would ensure that written deliverables, such as clinical study reports, informed consent forms, patient narratives, manuscripts and abstracts, would be accurate and of good quality.
Clinical Data Management
This is one of the areas in which technology can create the greatest impact by means of automating time-consuming steps like database design and data collection. These decision support services could have a major impact on the overall aim of bringing the product to market faster.
Biostatistics and Quality Assurance
Opting for a CRO partner ensures that the coordination of clinical trials becomes a more streamlined and guided activity at every step, from study design to the final manuscript. The vendor would come in with the required expertise for all audit and training needs.
Choosing the right CRO partner can provide you an extensive range of expertise in the area and help your company achieve its final goal of getting the product to the market in optimal time.
To know more about the topic please visit HCL Technologies.
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