Dispelling myths about bioequivalence studies being cheaper to do on paper than with EDC / IWRS systems.

10 November 2017

Dispelling myths about bioequivalence studies being cheaper to do on paper than with EDC / IWRS systems.

One of the main goals of Data Management 365 is continuous improvement of clinical research data quality and optimization of clinical trials, including BE studies. Data Management 365 have developed their own approach to conducting a BE study. 

What is the feature of data management in BE studies? Shorter CRF, faster building in EDC, fewer queries, quicker Data Manager's reaction. Less work - less time, less time - less budget for EDC & IWRS.

Answer three simple questions: 

Do you always receive the expected quality of DM services for BE studies? 

If the quality was perfect, were you satisfied with the budget? 

Is it important for you to be regularly informed about the progress of vendors’ work?

So, what to focus on? Should you sacrifice quality for the cost or maybe shorter schedule?

DM 365 specific approach to BE studies guarantees data collection and cleaning using a validated EDC and reliable quality system at the price of paper CRF or even cheaper. Our team pays special attention to the quality management system. For 3 years we have been building and optimizing the processes of BE projects and creating all the necessary templates. Automated processes, electronic systems, including eTMF (structured according to DIA Reference Model), allow us to reduce costs without losing quality or extending schedules..

Even if you have performed more than 100 BE studies, we still have something to share with you. Data Managers are ready to give expert advice in the field of DM, EDC, IWRS, data export and develop a CRF from scratch. Our professional testing department worked with more than 50 eCRFs of various complexity. Over the past 3 years, we have received only positive feedback on BE studies from clients. All the BE projects were completed on time.

Project teams demonstrate a responsible attitude that you will certainly notice. We support our clients throughout the project: HelpDesk quickly responds to technical questions, responsible Data Manager helps with DM-related inquiries, Project Manager monitors the timelines and each deliverable, QA Manager will not allow deviating from the regulatory requirements and company SOPs!

Call or email us anytime. We will be happy to advise you on data management in clinical trials, including BE!