Services

MPB Biostats has a license for SAS version 9.4 and utilizes Enterprise Guide version 8.2. SAS is installed and validated per SAS installation guidelines.

Detailed by item deliverables are predetermined and are estimated so that the client knows what they will be receiving and will know the total cost involved.

MPB Biostats does not take ownership of writing protocols for clinical studies. However, we will review protocols during the synopsis and draft stages to help ensure the study objectives and design are appropriate for the client from a statistical point of view.

MPB Biostats does not offer data management services. However, we will assist in reviewing the CRF and other data related documents to help ensure the correct data is being collected for a study.

MPB Biostats provides the service of creating statistical analysis plans (SAP) that will be signed off by the sponsor. We will also review as a secondary statistician if the production of the SAP is provided by the vendor/sponsor.

Prior to executing the study results, mock TFL shells should be provided to help ensure the client is receiving their results in the requested format. We can take on the production of this task or review the vendor/sponsor’s work.

Multiple FDA divisions require study data to be submitted in a tabular format using CDISC SDTM standards. We are capable of providing full service and FDA submission ready CDISC SDTM packages. This includes XPT datasets, annotated CRF, Define XML, and Study Data Reviewer’s Guide. SDTM datasets are validated using Pinnacle 21 Community (formerly known as OpenCDISC). Additional details can be found on the CDISC website at https://www.cdisc.org/

We are also available to review any vendor’s CDSIC components to help locate any potential errors found in their deliverables. A detailed Excel spreadsheet will be provided with specific concerns regarding their work.

Multiple FDA divisions require study data to be submitted in an analysis format using CDISC ADaM standards. We are capable of providing full service and FDA submission ready CDISC ADaM packages. This includes XPT datasets, Define XML, and Analysis Data Reviewer’s Guide. ADaM datasets are validated using Pinnacle 21 Community (formerly known as OpenCDISC). Additional details can be found on the CDISC website at https://www.cdisc.org/

We are also available to review any vendor’s CDSIC components to help locate any potential errors found in their deliverables. A detailed Excel spreadsheet will be provided with specific concerns regarding their work.

MPB Biostats creates both CDISC SDTM and ADaM Define XMLs using Pinnacle 21 Community (formerly known as OpenCDISC). These documents are also validated using the same software.

Templates provided by PhUSE are used by MPB Biostats for creating the Study Data Reviewer’s Guide for CDISC SDTM and Analysis Data Reviewer’s Guide for CDISC ADaM. These documents describe any odd data collections and/or findings throughout the study.

MPB Biostats has extensive experience in creating tables, figures and listings using SAS for a wide variety of therapeutic areas. We have the capabilities of providing production TFLs as well as full QC/validation of the deliverables.

MPB Biostats does not take ownership of writing Clinical Study Reports (CSR) for clinical studies. However, we will review statistical portions of the CSR during draft stages to help ensure the study conclusions have been properly written from a statistical point of view.

Integrated Summary of Efficacy and Integrated Summary of Safety are required for FDA NDA submissions. We have extensive experience filing for NDA submissions and integrating multiple studies together for ISE/ISS packages.

For detailed graphical layouts concerning patients, we can provide these unique sponsor specific figures for clients.

For deliverables during the draft stages or items that are not planned, we can provide ad-hoc requests at any point during the study. Once the study’s database has locked, we can provide post-hoc requests as well.

To help eliminate biasness for a clinical trial, randomization schedules are sometimes required for treatment allocation to patients. We provide a wide variety of study design randomizations based on the client’s request. All randomizations are produced using SAS software.

For clients/vendors who need a particular set of data formatted differently than the raw format collected, we can manipulate the data in the specific format requested based on data specifications. Output files can be produced in Excel, text, SAS, XPT, etc. depending on the request of the client.

Michael Burak, of MPB Biostats, has had extensive involvement in 2 successful NDA submissions and 1 BLA submission while working for biotech companies in the past. All 3 of these drugs were approved by the FDA.