Data Solutions (Clinical & Post-Marketing)
MakroCare provides customer with full service centralized data services for investigations or post-marketing clinical follow-up studies. MakroCare develops flexible and customized data management plans to accommodate different device needs (from class IIb to class III).
With deep global experience in managing data for paper-based and electronic studies across all countries, MakroCare can collaborate with customers to efficiently manage patient data and helps to meet desired safety, performance and clinical evidence objectives in a cost-efficient manner.
Our Team comprises of strong talent pool of data managers and data scientists with experience who are well trained in ICH-GCP and GCDMP with work exposure across the device therapeutic areas having expertise in handling data for regulatory or marketing purposes.
EDC and Registry Technology Expertise:
We at MakroCare have experts in EDC technology to understand the project’s requirement and to capture clean and accurate data meeting the timelines and customer budget.
With Electronic Data capture, MakroCare can provide its customers several Operational and cost benefits. MakroCare can recommend best EDC (or directly getting data from EMR) strategy that suits the study’s requirement. Our data team has vast experience in providing data management services using various technological platforms and can collaborate with you to choose the option that best meets your program needs.
MakroCare Data Services Advantage:
We at MakroCare have proprietary Tools that benefit deployment of effective clinical data solutions cost effectively. Our Services covers activities ranging from designing data intake or case report form (CRF) forms to data cleaning documents to validation steps to database design to database lock and report submission.
Our tools constitute comprehensive electronic data capture system ‘mEDC’, advanced reporting system ClinMet, Customizable CRF design application’ Dattasa’ Centralized document management system ‘jarTree’.
Please email us to discuss on your device data requirements for clinical evidence for Health Authorities or NB approvals