Bollinside Programming Services

Tap into extensive expertise and a wide range of experiences from a journey of more than twenty years in clinical information delivery that remains active in ensuring the bringing of new medicines to the market on time and the enhancement of the potential of existing marketed medicines.

Consultancy Services on Offer

• Design, development, deployment, implementation and support of new computing platforms and other tools used for clinical information delivery.

• Data standardisation using CDISC data standards like SDTM and ADaM that are documented using Define-XML and Data Reviewer’s Guides.

• Delivery of clinical information across all phases of clinical development from Phase I to Phase IV together with regulatory submissions that result in successful new medicine registrations.

Recent Successes

• Development of an automated toolkit for producing data listings for Part II of the OSI BIMO requirements for FDA regulatory submissions.

• Creation of a suite of SAS macros for directing clinical results output to Microsoft PowerPoint for communication to senior management and at regulatory meetings. This replaced a manual process that was time-consuming and subject to error.

• Development of a macro usage reporting tool to assess the use of common programming tools and identify areas for improvement. The results were instrumental in the decision to examine ways to further standardise efficacy output programming. These ranged from the creation of a suite of standard TA-specific template programs to a new system for output template definition and code generation.

• Enhanced suite of common tools macros to incorporate improvement requests from users and to ensure portability between two programming platforms. The number of new issues reported by users was reduced by less than half.

A Solid Track Record

• Successful delivery of dozens of study analyses across a range of therapeutic areas that includes oncology, CNS, CV and urology.

• Supported numerous successful regulatory submissions using extensive programming and CDISC expertise.

• Training of multiple regulatory submission teams on the use of SDTM and ADaM.

• Development of the following components for a statistical computing environment:

  • Program building component of its CDISC study data mapping tool.

  • Output consolidation tool that combined textual and graphical study analysis output into the same bookmarked PDF file in order of section and output number, along with a table of contents.

• Continually expanding expertise of a range of technologies that includes SAS, R, Python, Julia and XML with knowledge of other technologies constantly being added.