Post Approval

Phase IV and Post Approval

DataCeutics supporting your phase IV trials and post approval needs

DataCeutics can help with your Phase IV and post approval needs. We offer comprehensive services that are custom tailored to your needs to promote quick and accurate submissions.

Biostatistics and statistical programming using SAS®

DataCeutics provides outstanding statistical analyses and programming support for phase I clinical studies across a wide range of therapeutic areas. From input into the design of the Statistical Analysis Plan (SAP) to performing analysis, DataCeutics can assist you. Our clients regularly recognize members of our team of M.S. level and Ph.D. level statistical programmers and biostatisticians for producing quality work, being responsive, and for maintaining the highest level of professionalism throughout each engagement. Using SAS® to generate STDM datasets, ADaM analysis datasets, tables, listings and figures for Regulatory Submissions are just some of our specialties. Other routine services include annual safety updates, developing patient registries and post-marketing publication support. For more information see Statistical Programming & Clinical Reporting.

Clinical data management

For more than 18 years, DataCeutics has been providing clinical data management services for Phase II and III clinical trials. During this time, we have been busy using our expertise to help our clients with services in the areas of database set-up and build, edit check programming, data entry, data listings, patient profiles, STDM dataset generation, ADaM dataset generation, custom clinical programming, systems validation and much more. For more information see Clinical Data Management.

SAS®-based clinical reporting systems

DataCeutics has both the SAS® and Clinical Reporting expertise to help you implement a clinical reporting system. Our professionals have extensive experience implementing clinical reporting systems such as SAS Drug Development and Waban SCE as well as custom SAS®-based biostatistics/clinical reporting environments.
DataCeutics SAS®-based reporting systems include the DataCeutics Report Portal (DRP) and the CR Toolkit SAS Macro-based TLF generator. For more information see SAS®-Based Clinical Reporting Systems and Technology Solutions.

Industry data standards and regulations

One of DataCeutics robust capabilities is our experience CDISC data standards. Our company possesses a clear-cut advantage with our experience in Phase IV studies, across most all therapeutic areas. DataCeutics can immediately help with the building of CDISC SDTM compliant databases. We have been an active member of the CDISC group since the inception of CDISC over ten years ago. DataCeutics has a central Standards team to focus on internal CDISC training, the development and expansion of DataCeutics’ own standard methodologies, and the review of SDTM and ADaM being delivered by DataCeutics teams. For more information see CDISC Data Standards.

QA Compliance

DataCeutics is an industry authority in computer system validation and systems compliance. DataCeutics implements best practices in computer systems compliance. DataCeutics Validation Methodology (DVMSM) ensures that computer systems are planned, designed, developed, tested, installed, operated, maintained, and archived according to regulations and acceptable industry and Company standards. Validation and 21CFR Part 11 compliance are critical elements in the development and support of our software products and services. For more information see QA Compliance.

Project management

The DataCeutics project management approach is focused on achieving success and reaching client goals. Our process allows us to deliver quality results that are within scope and budget with outstanding support. Our proactive approach helps us to identify possible hurdles up-front, so we can minimize risk and strategize to develop alternative paths to client success. For more information see Project Management.

See our unique Value Proposition and why you should always choose DataCeutics as your Preferred Vendor.

• Biostatistics
• SAS® Statistical Programming
• SAS® QC/Verification/Validation
• Protocol Deviation Programming
• SAS® Verification Programming
• Clinical Reporting Tools
• SAS® Systems Development
• Systems Development Life Cycle Methodology
• IEEE Development Methodology
• Standards Implementation
• CDISC CDASH/STDM and ADaM Services
• Electronic Submissions
• Statistical Computing Environment Support
• IT Environment Support
• Clinical Study Report Auditing