Clinical Data Management
Clinical data management is a complex, heavily-regulated process that even the largest clinical organizations have difficulty navigating. Ofni Systems can validate and improve your current clinical data management systems or provide turn-key in-house or client-site solutions for many required data management processes.
Clinical Data Entry to Database Lock
Once your Ofni Clinical database is fully functional, our professionals can prepare your clinical database to database lock quickly and efficiently. Ofni Systems can perform all of the phases required to get your database report- and analysis-ready, including:
- Double Data Entry and Reconciliation: Our trained data entry personnel can rapidly transfer your Case Report Forms and other subject or patient information to the database and perform the required data reconciliation.
- Data Cleaning: Ofni Systems can recommend and implement appropriate correctness and completeness checks to ensure that data cleaning is an efficient and painless process.
- Query Generation and Resolution: Ofni Systems can efficiently generate, transmit, and resolve any and all queries resulting from the clinical database using the features built into the Ofni Clinical database.
- Database Lock: Our data entry, reconciliation, and resolution services can get you to database lock rapidly and Ofni Clinical databases make locking fast and efficient.
Custom Trial Analysis Services
Ofni Systems’ data management services do not stop on database lock. We can perform any of the post-lock services including:
- Data Cleaning and Reformatting: Ofni Systems will clean and reformat the data to your standards or to industry standards such as the CDISC formats.
- Reporting: Ofni Systems can generate custom tables, listings, figures, and reports for your data, either as part of the Ofni Clinical database or as separate documents.
- Statistical Analysis: We can perform statistical analysis of pharmaceutical, medical device, or observational data with respect to safety, efficacy, and pharmacokinetics or toxicokinetics.
- Statistical Reporting: Ofni Systems will produce clinical trial statistical reports for any statistical analyses and can write statistical sections for your Investigator’s Brochure or Clinical Study Report.
- Additional Clinical Statistical services: Statistical Analysis Plans (SAPs), generation of trial randomizations, and all other required statistical clinical services.
Additional Clinical Products, Services, and Support
Ofni Systems performs a wide variety of clinical services:
- Customized Clinical Data Management – We can perform any or all of the clinical data management process from database creation to finished reports to match your exact specifications.
- Compliance Reviews and Auditing – Ofni Systems can ensure that your organization meets regulatory requirements and can help you become compliant if a gap is identified.
- Validation – We can produce an executed validation package for your database in days, not months.
- Assistance with Data Conversion – Ofni Systems can assist with converting your paper records to electronic data or converting your electronic data to other formats.
Please contact us for a quote on any of our clinical products, services, or support.
Learn more about Ofni Clinical