Clinical Data Management Services
Makrocare provides customer with centralized, coordinated data management services for local and international studies. We handle all phases of clinical research across the full spectrum of therapeutic areas. MakroCare develops flexible and customized data management plans to accommodate each customer specific study needs. We also offer customized reports to customers at timely and periodical intervals to get the complete feel of the conduct of study.
CDM Team's Expertise at MakroCare
With vast global experience in managing data for paper-based and EDC trials across all phases, MakroCare can collaborate with customers to efficiently manage clinical trial data and helps to meet desired business objectives in a cost-efficient manner.
Our Team comprises of a pool of highly talented data managers from CRO industry with vast experience who are well trained in ICH-GCP and GCDMP with work exposure across the therapeutic areas having expertise in handling clinical trial data from Phase-I to Phase-IV studies for Submission to Regulatory bodies (Local and International).
EDC Technology Expertise:
We at MakroCare have experts in EDC technology to understand the customer's requirement and to capture clean and accurate clinical research 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 strategy that suits the customer's requirement. Our expert team has vast experience in providing CDM services using various EDC platforms and can collaborate with you to choose the option that best meets your program needs. As per customer's technology requirement, MakroCare team will ensure that the database and validation checks are deployed accurately and quickly, so that sites and users are trained on the system, and that results are available in a clean database, which is locked on time with good quality. We also facilitate 24/7 support on data management solutions by providing unparallel assistance during the conduct of trial.
MakroCare CDM Services Overview:
MakroCare CDM Advantage:
We at Makrocare have portfolio of Tools which benefits to deploy CDM solutions cost effectively. Our Services covers activities ranging from case report form (CRF) and database design to database lock and report submission.
Our tools constitutes comprehensive electronic data capture system ‘mEDC’, advanced reporting system Clinmetanoia, Customizable CRF design application ‘Dattasa’ Centralized document management system ‘jarTree’.
Risk and Backup Plan:
We at MakroCare Focus on the availability of the key business processes to continue operations should any kind of disruption arise. Our BCP addresses all mission critical resources required to continue as a viable organization. Our Risk Management helps us in deciding the extent of provisioning for alternate facilities as agreed with customer.
Our Backup solutions are:
- Simple, effortless and continuous Data protection.
- Adherence to minimum RTO margin.
- Increased reliability with GFS (grandfather-father-son) Tape based solution.
- Combination of incremental, differential and full backup strategy as needed by the business.
- Incorporates data de-duplication and common file elimination to reduce the total amount of data stored.
- Includes several robust encryption options.
- Intangible benefits like Business Continuity Management.