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...]
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 biostatical 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.
MPB Biostats also has a working relationship with multiple independent biostatistician and SAS® programming consultants in the pharmaceutical industry. We provide our clients with each consultant’s CV for any considered potential candidates. MPB Biostats will follow any confidentially terms set forth by the client in relation to working with subcontractors. Our infrastructure has the capacity to bring on SAS® programming experts in order to assist in producing/QC CDISC SDTM/ADaM submission packages and TFLs. MPB Biostats will work with any outside consultants/vendors hired by the client as well.
Michael P. Burak, M.S.
Michael has worked in the pharmaceutical industry for over 10 years working for a CRO, 2 biotech companies, and started his own consulting business. Within those years of experience, Michael has 8+ years of senior level/management/ownership experience. During this time Michael has been involved in 3 successful eCTD NDA/BLA submissions in which all drugs were later approved by the FDA.
Michael’s 10+ years in the field includes biostatisticial experience which consists of protocol development, sample size calculations, generating SAPs and mock TFL shells, regression modeling, ANCOVA modeling, and writing statistical summaries. However, Michael generally chooses to review this type of work as a secondary role in order to allocate more time towards SAS® programming.
Lorin Burak, VP of Project Management & Business Development, joined MPB Biostats Inc. in 2016. She has over 15 years of sales/management/leadership experience managing teams of up to 25 employees. Lorin reviews and provides feedback on protocols, SAPs, aCRFs, CDISC define documents, Reviewer’s Guide for CDISC SDTM/ADaM, CSRs, and TFL outputs.