MPB Biostats Inc. was founded in March 2014 by Michael Burak. MPB Biostats Inc. 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 Inc. produces high quality results quickly and efficiently for their clients. MPB Biostats Inc. has vast experience with pre-clinical trials, phase I-III clinical trials, ISE/ISS database integrations, successful NDA & BLA eCTD submissions, and FDA regulatory inquiries. Areas of therapeutic concentration include pharmacokinetics, gastroenterology, immunology, dermatology, medical devices, oncology, obesity, and depression. MPB Biostats Inc. 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 Inc. All employees of MPB Biostats are required to have GCP training and are certified online by NIDA Clinical Trials Network. MPB Biostats has a list of SOPs that each functional area and external consultants follow and is willing to be trained on any current/future clients’ company’s SOPs.