Clinical data management is a complex, heavily regulated process that even the largest organizations often need help with. Ofni Systems can help 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 get 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.
- Creation of Discrepancy Checks: 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 facilities 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.
Our statistical services are not limited to post-trial work. We can also write Statistical Analysis Plans (SAPs) and generate trial randomizations.
Custom Clinical Solutions
Ofni Systems can implement customized clinical data solutions to your requirements. We can perform any or all of the clinical data management process from database creation to finished reports to match your exact specifications. Please contact us for a quote.
- Complete Customer Support - Ofni Systems professionals want to work with you to ensure that your clinical trial meets and exceeds all Clinical Trial requirements.
- Compliance Reviews and Auditing - Ofni Systems can ensure that your organization meets all regulatory requirements and 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 Entry and Data Reconciliation - Ofni Systems can assist with converting your paper records to electronic data and reconciling any issues in data entry.
Our goal is to ensure that your clinical trial exceeds all requirements for clinical trials.
Learn more about Ofni Clinical
|
|
> Ofni Clinical Group