Clinical Data Management – process of collection, data cleaning, and management of data in compliance with regulatory standards. At Abiogenesis, our Clinical data management team ensures accuracy and reliability of the clinical trial data in compliance with regulatory standards
Study Setup
At Abiogenesis Clinpharm Study set up includes pivotal activities for effective clinical trial management. It starts with the creation of explanatory Case Report Forms (CRFs) and electronic CRFs for structured collection of trial data. CRFs are then annotated for clarity, and slotted into a robust eCRF build that validate the data entry stages. Our Data Management Plan provides a gist of data handling procedures whereas Database Design & Setup helps in the safe storage and organization of clinical trial data. Data inconsistency is identified and prevented with Edit Check Specifications & Programming to maintain the data quality. We have a configuration of data loading setup and important dictionaries such as MedDRA and WHODDs. And lastly, we seamlessly integrate the IVRS and IWRS systems into the database to manage participants and collect data efficiently.
Study Conduct
We at Abiogenesis Clinpharm conduct clinical trials, taking into consideration all the regulatory guidelines and procedures. Our team of professionals review the data and manage the queries that arise during clinical trials. The data generated during clinical trials is stored in our database and our clinical data management team ensures that medical coding is performed according to the medical dictionaries i.e. MedDRA and WHO-DDE. We examine causality of SAE’s to determine the possibility of any adverse event, apart from that we collect data from external sources such as Central Lab, e-Diary, etc. to ensure third party reconciliation. Any post production changes are recorded in our database and customized reports are generated for review and analysis. We maintain confidentiality throughout the data transfer process.
Study Close-Out
Abiogenesis Clinpharm ensures a smooth transition from data collection to data analysis and archiving. Our interim analysis readiness allows us to prepare data for early insights during the clinical trial. We clean and rectify the data to eliminate inconsistencies by conducting a thorough QC in database. We then securely lock the database once all the data is final and has passed rigorous quality control processes to maintain the integrity of collected results. Abiogenesis expertise facilitates a secure and efficient data transfer process using encryption and other security methods to protect the data maintaining data integrity. We also provide archival or decommissioning services to protect your data and maintain compliance with government regulations.
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.
