Clinical Data management is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. At Abiogenesis Clinpharm our Clinical data management team provide high quality data by keeping the number of errors and missing data as low as possible and gather maximum data for analysis. Moreover, Clinical Data Management is a crucial phase in Clinical research, which in turns generate top quality, effective and statistically relevant data from clinical trials, this results into drastic reduction in time from drug development to marketing. Various procedures in Clinical data management includes Case report form designing CRF annotation, database designing, data-entry, data validation, data extraction are assessed for quality at regular intervals during trial.
Clinical Data Management Services
Tools for Clinical Data Management
Our database development team have experience in designing , setup, implementation, maintenance and closure of various data management solutions which are 21 CFR part 11 complaint
Standard Operating Procedures
Our CDM SOPs are tailored to accommodate in handling the complex clinical trial data right from understanding the user specific requirements till the data base lock involving all the stake holders which will empower the team to perform the tasks efficiently without having any delays in the lifecycle management of the CDM process By adhering to these SOPs, Abiogenesis, ensures that clinical trial data is managed with the utmost integrity and reliability
Regulations, guidelines and standards
Regulations are applicable to records in electronic format that are created, modified and maintained, this demands the use of validated system to ensure accuracy, reliability and consistency of data. Electronic-data have to comply with 21 CFR part 11.
Patient Data Privacy
In clinical trial data management, patient data is highly sensitive, so being a CRO it is our prime responsibility to shield the patient’s information and other relevant data related to clinical trials. At Abiogenesis , we make sure we follow all the required regional regulatory compliance to ensure that all patient data is handled with the highest level of security and confidentiality
Risk Identification and Mitigation
Our Clinical data management team takes the initiative right from the beginning to identify risks, assess their impact and develop a comprehensive risk management strategy. Our approach is to implement mitigation strategies for trial success
Our team at Abiogenesis Clinpharm, excels in management of clinical trial data by maintaining data integrity, prioritizing patient safety and adhering to regulatory guidelines. By establishing and implementing SOPs for effective clinical trial data management and using different tools for data management, we ensure validity of clinical trial data throughout the trial process.