Lotus Labs Clinical Data Management (CDM)
Lotus Labs Clinical Data Management (CDM) team has vast experience in the process of collection, cleaning and management of subject data in compliance with regulatory standards. The team works towards providing high-quality data by keeping the number of errors and missing data as low as possible and gathers extensive data for analysis.
The team provides Data management services, Report writing and Regulatory submission services in best in class timelines in the industry. The team has rich experience in handling various industry benchmark EDC tools such as ORACLE CLINICAL, InForm and RAVE.
Lotus Labs CDM team provides end to end data management services from Study start-up to Study closeout as described below:
Study start up: Preparation of data design specifications, eCRF designing, data management plan preparation, Preparation of data review specification, edit check programming, user acceptance testing, IWRS services.
Study conduct: Study Data review & cleaning, Medical coding, Safety data review, lab data reconciliation, IWRS data reconciliation, Project specific documentation.
Database Lock: Freezing and locking of data after thorough review and error rate acceptability approval by Quality Assurance.
The team has handled studies across various therapeutic areas as below:
- Infectious diseases
- Woman Health
- Quality of life studies