WHAT IS A CRO?
Understanding Clinical Data Management
Clinical Data Management (CRM) plays a key role in clinical data collection. Effective clinical data management services facilitate efficient access, processing, summarization, and dissemination of data and information. During clinical research and trials, it is crucial that as much accurate data be collected for analysis as possible. All data must conform to strict regulatory standards to ensure quality data is always maintained.
Clinical Data Management is a growing industry that developed to help pharmaceutical products and devices get into the marketplace as quickly as possible while meeting the strict demands of regulatory authorities.
The following Clinical Data Management questions are answered below:
- What Are Clinical Data?
- What is the Role of a Clinical Data Manager?
- What Is The Work Of Clinical Data Management?
- What Are Edit Checks In Clinical Data Management?
- Why Is Clinical Data Management Important?
What Are Clinical Data?
Clinical data is the data that’s collected during a clinical trial. This data informs decision makers in the pharmaceutical industry on whether or not the product being developed is safe and provides value. If the data does not support this standard, the product will not be developed, and vice versa.
What is the Role of a Clinical Data Manager?
A Clinical Data Manager, sometimes known as a Clinical Data Coordinator, plays a critical role in the organization and management of a clinical trial. They oversee the manner and method in which data is collected by carefully designing the data collection tools based on the clinical trial protocol. They collaborate with the research team to ensure all available data is collected, validated, transmitted securely, and consistent with other data collected during the clinical trial.
What Is The Work Of Clinical Data Management?
The work of Clinical Data Management covers a range of clinical data services that aim to meet the demands of the pharmaceutical industry as well as the high standards of clinical trial regulatory requirements. Clinical Data Management services may include:
- Case Report Form (CRF) Design
- Format data collection forms
- Indicate study data fields and allowable responses
- User-friendly CRF design
- Clinical Data Management Plan
- Detailed database design specifications (DDS)
- Written data management plans
- Risk analysis assessment
- Database development checklist
- Database validation plan
- User acceptance test plan
- Data processing guidelines
- CRF review and data cleaning guidelines
- Validation reports
- Clinical Database Development
- Study-specific data entry screens
- Back-end tables
- Automated edit checks
- Clinical Data Entry, Data Processing, CRF Review, Query Resolution
- Site monitoring
- Double data entry
- Controls for data entry accuracy
- Detect data inconsistencies
- Data Dictionary Processing
- Data coding services
- MedDRA and WHO DRUG
- Coding listings
- Data Imports
- Data import protocols
- Sponsor submissions
- Data Exports
- Excel spreadsheets
- SAS datasets
- ACCESS tables
- ASCII files
- Data Quality Assurance
- Generation and review of data inconsistency listings
- Confirmation of randomization schedules
- Data entry versus source data
- Resolution of data queries
- Data reports
- Study data analysis and metrics
- Database Lock and Data Transfer
- Data lock checklist
- Clinical study database lock
- Transfer to designated biostatistician for analysis
- Database Maintenance and Archival
- Maintain clinical databases
- Final clinical study report
- Transfer clinical study data
- Data formatted
- Data archived
- Security Procedures
- Specific access roles
- Interval changes for user passwords
- Audit trails of server and record access
- Track modifications made to data and files
- Restoration of data
- Secure storage
- Data backups
What Are Edit Checks In Clinical Data Management?
Edit checks in Clinical Data Management ensure all data meets the previously defined rules. They help to validate the reliability and quality of the data collected. Edit checks are vital to the clinical trial process as they can detect inconsistencies in the data for the most accurate data collection and management.
Why Is Clinical Data Management Important?
Without clinical data, pharmaceutical products, devices, and developments cannot advance. Quality assurance is a top priority in any medical field, and to guarantee quality, large amounts of data are required. Clinical Data Management is vital to the medical product evaluation process, ensuring all medical products help meet patient needs and adhere to regulatory requirements.
The needs of the pharmaceutical industry develop and evolve at a rapid pace. In order to keep up with industry demands, clinical professionals and institutions must conduct research and trials more quickly than ever before, while never reducing the quality of testing. Clinical Data Management ensures a speedy trial process that meets all regulatory requirements. A faster trial process can also offer medical institutions a reduction in costs.
The FDA, as well as other relevant regulatory authorities, require complex and accurate data for approvals. Clinical Data Management ensures that all clinical data produced and collected is of the utmost quality, adheres to current protocols, and contains absolutely no inaccuracies.
Security is of top importance when it comes to medical data. Any clinical trial and the associated collection, maintenance, transfer, and storage of data must adhere to standard best practices with respect to data security. When dealing with personal data, security must be maintained, and it’s equally important that all data is secure and backed up to protect from any possible loss of said data. Clinical Data Management securely collects, maintains, stores, and transfers all clinical data.
Clinical Data Management with PMI
Promedica Intl. (PMI) delivers the quality and consistent results of a large Clinical Research Organization with the efficiencies and responsiveness of a small CRO. PMI offers data management services that are scalable to your needs. We emphasize well-organized, appropriately documented, accurate, and timely processing of all clinical data.
PMI’s quality control procedures for statistical
output involve a combination of independent programming
and internal review to verify accuracy and completeness
of tables, figures, and listings.