Pinnacle 21 Community (formerly known as OpenCDISC) has released their free software download upgraded version 2.2.0 for compliance checks for CDISC SDTM, SEND, ADaM, and … [READ MORE...]
About MPB Biostats
MPB Biostats Inc. was founded in 2014 by Michael Burak. MPB Biostats offers statistical and SAS® programming support for pharmaceutical companies, biotechnology companies, medical device companies, contract research organizations (CROs), and other independent consultants. Whether it is a full service project or small ad-hoc requests, MPB Biostats has the capabilities of producing high quality results in an efficient and detailed manner.
MPB Biostats is experienced in pre-clinical trials, phase I-III clinical trials, ISE/ISS database integrations, successful NDA & BLA eCTD submissions, and FDA regulatory questions. The main therapeutic and other areas of concentration experiences include depression, dermatology, gastrointestinal, immunology, medical devices, obesity, oncology, and pharmacokinetics.
MPB Biostats primarily focuses on SAS® programming for clinical trials and specializes in creating CDISC SDTM/ADaM submission packages, creating TFLs, and ad-hoc/post-hoc requests. Other planning and reporting biostatistical services such as randomization schema, SAP, mock TFL shells, CSR review, reviewing statistical components of an eCTD NDA/BLA submission, and statistical reports may also be provided by MPB Biostats.