Clinical studies or trials continue to increase in complication and scope, a typical phase 3 protocols, for instance, now has many endpoints, processes and data points gathered compared to a decade earlier. At the same time, data management procedures have become more complex, as CROs or contract research organisations and sponsors manage a variety of clinical study data.Real-time proof, electronic clinical result evaluations, mobile device-oriented data, social media interactions and electronic health, as well as medical records, are some of new data sources that are now captured during the clinical studies.
Whether hosted on-premises or on the compliant cloud, the experienced data managers are successful in the execution and integration of the widely used and sought-after clinical and edc applications. Additionally, assisting you to choose, execute, integrate, utilize and monitor an assortment of systems, efficiently and cost-effectively help with software licensing, relocations and upgrades.
The services and industry software enables the system of clinics due to clinical trials to stay up and running. The results are faster, and better for the business.
Clinical data management
Life sciences enterprises rely on the systems to gather and monitor clinical data in a dependable, consistent and regulatory compliant way. As more companies compete in the structure of drugs, therapies, and devices, the demand for cost-efficient and effective clinical data management and electronic data capture or EDC solutions are increasing. The data managers specialize in the execution as well as the integration of the clinical data management solutions that will enable the business to design and uncomplicated clinical trials efficiently.
Clinical trial operations
The team of clinical trial operations has deep and intricate expertise in implementing as well as integrating leading clinical studies management systems. These solutions serve as a core responsibility of clinical study management details and offer greater visibility into real-time website and study statuses.
With the critical data at the fingertips, the clinics will be empowered to make more informed decisions. To make the clinical study management solutions even more useful and acquirable, the developed accelerators significantly lower implementation costs and timeframes and encompass robust abilities that lead to an efficient clinical study procedure.
Safety and Pharmacovigilance
Proving the efficacy and safety of device, drug, and therapy is quite critical. The procedure of bringing a breakthrough product in the market includes many parties like doctors, researchers, patients, government, clinical research institutes, and corporations. As the number of involved resources in the product development increases, reporting on and evaluating data has become complex, in order to effectively fight the complication of safety and risk management, organizations are investing in Electronic Data Capture applications.
Manual capture vs. Electronic data capture or EDC
- Highly time-consuming, which means that precious time could be lost in manually collecting the data.
- Highly difficult for the data managers to gather accurate information.
- Highly difficult for research purposes.
- Manual captures also results in immense complications in the terms of storing it and accessing it later for future purposes.
Electronic data capture (EDC)
- The best thing about EDC is that the data collected can be relied upon, unlike the case which is with manual capture.
- EDC is a huge time saver for data managers.
- The data collected through EDC are efficient in getting fast-track approvals.
- The data gathered through EDC will be easily accessible by the doctors and researchers whenever needed.
- The data integration applications are the best platform to access the data assembled through EDC
Opting for EDC rather than resorting to the measures of manually capturing data will be a wise decision to prevent any inconvenience to the users.
Design your eCRF for multiple studies, we have specialized EDC features as Autochecks/edits, Graphical dashboards, Medical coding, paper-based studies, Multiple formats and easy configuration.
For Quality Data Management, Please contact Globalpharmatek.