Resources

Below are just a few of the credentialed resources you will find at Octagon, who contribute to the development of our e-Clinical Solutions. Each of these team members has extensive industry experience and practical knowledge of the clinical data lifecycle.

Dan Crawford

Director, Clinical Data Strategies

Dan Crawford serves as Director; Clinical Data Strategies at Octagon Research Solutions, Inc. Dan has over 17 years of experience in clinical data management and is a frequently requested presenter at industry conferences. He has direct experience in data management and in the implementation of clinical data standards.

Dawn Kaminski

Product Manager - EDC, Product Management

Dawn Kaminski serves as Product Manager for the ViewPoint^® FUSE EDC product. Dawn has over 11 years experience in clinical data management and has worked in all facets of Data Operations. At Octagon, Dawn is responsible for all releases and enhancements to the ViewPoint^® FUSE system as well as future product planning.

David A. Evans

Chief Information Officer

Mr. Evans is a senior technology and clinical research executive with over twenty years experience in the clinical research, regulatory and healthcare industries. He has served in many industry leadership roles, among them as Chief Technology Officer for a leading clinical research organization, as Chief Operating Officer for a clinical software development firm and as Chief Technology Officer for First Genetic Trust, a provider of comprehensive, secure information technology infrastructure to support the development and adoption of genetic based medicine and diagnostics.

Mr. Evans has been elected as the Chair-elect of the CDISC Advisory Board (CAB) for the 2010 calendar year. The CDISC Advisory Board is comprised of representatives of the corporate sponsors of the CDISC organization. Members of the board are appointed by their respective industry organizations to serve on the board. The board serves to provide input, advice and governance during the development of the CDISC organization's strategic plan as well as during the implementation and execution stages of the plan. The membership of the CAB participates in the active communication of the CDISC vision and mission to their organizations and to the industry in general. Dave will be serving as the Chair of the CAB during the 2011 calendar year.

Luke Brennan

Vice President, Global EDC Operations

Mr. Brennan serves as vice president, Electronic Data Capture (EDC) and is responsible for developing the strategic and technical vision for Octagon’s EDC technology solution as well as leading Octagon’s West Coast Operations. He brings over 20 years of experience in the design, development and delivery of clinical information systems for healthcare and clinical trial technologies for the pharmaceutical and biotechnology industries with a particular focus on EDC technologies.

Prior to joining Octagon, Mr. Brennan served as vice president, Operations at Ninaza where he was responsible for managing the day-to-day business operations for Ninaza’s EDC product. Prior to Ninaza, Mr. Brennan served as vice president, Implementation Services for Medidata Solutions where he managed professional and implementation services for the company’s EDC customer implementations.

Matt Stroschein

Vice President, Global Operations

Mr. Stroschein joined Octagon in 2000 and was Octagon’s 4th employee. He currently serves as Vice President, Operations and has demonstrated success in reorganizing operations to improve customer service while creating internal efficiencies.

In his role as Vice President, Operations, Mr. Stroschein oversees Octagon’s Regulatory and Clinical Operations and is responsible for the development and implementation of distinctive cross-functional strategies. He has been instrumental in identifying integration points between clinical, regulatory and publishing functions and currently serves as the executive sponsor responsible for technology integration within Octagon’s submission processes.

During his tenure at Octagon, Mr. Stroschein managed the Regulatory Operations team, and electronic regulatory publishing projects while being directly responsible for project budgeting and set-up, proposal generation, process development, staffing of teams, facilitation of client relationships, and direction of project teams’ long-term and daily activities.

Terek Peterson

Director, Clinical Programming (CDO)

Terek Peterson serves as director, Clinical Data Programming at Octagon. He has over 17 years of experience in clinical and statistical programming and information systems. Mr. Peterson leads all clinical programming and statistical initiatives, including the development and implementation of enabling technologies within clinical data operations. Under Mr. Peterson’s leadership, the clinical programming team has completed 5 submissions with most of them using integrated ADaM analysis data. The team will be completing 2 more by the end of the year and several ISS and ISEs are planned for next year. Recently having joined the CDISC ADaM Team, Mr. Peterson has had the privilege of helping edit section three of the ADaM Implementation Guide that defines all the standard ADaM Metadata.

Prior to joining Octagon, Mr. Peterson held various statistical programming positions within industry, including Shire and Cephalon as well as various consultancy positions within global pharmaceutical organizations. He is a member of the Philadelphia SAS Users Group and serves on the Park and Recreation Board in Upper Providence Township in Delaware County. Throughout his career, Mr. Peterson has authored numerous bylines and is a frequent presenter at industry conferences.

Mr. Peterson holds an MBA from Rutgers University and two BS Degrees from the University of South Carolina.

David Izard

Director, Data Integration and Standardization

David Izard serves as director, Data Integration and Standardization at Octagon. Mr. Izard has over 18 years of industry experience with particular expertise in statistical programming, biostatistics and the implementation of emerging data standards. Mr. Izard oversees Octagon’s Data Integration and Standardization team where he is responsible for the strategic planning and coordination of all data integration initiatives. Under Mr. Izard’s leadership, the Data Integration and Standardization team has improved its process driven approach and related technologies as the team has grown 400% in the past 18 months, allowing Octagon to significantly expand its ability production of CDISC SDTM based submission deliverables.

Prior to joining Octagon, Mr. Izard held various analyst and programming leadership positions within industry, including Shire and GlaxoSmithKline. He has been actively involved in PharmaSUG (the Pharmaceutical SAS Users Group) as both a presenter and member of the conference committee for the past decade and has presented at numerous related conferences including NESUG and PhilaSUG. He was a member of the CDISC ADaM sub-team since its inception.

Mr. Izard holds an MS from West Chester University and a BS from Bucknell University.

Barry Cohen

Senior Director, Clinical Data Strategies

Mr. Cohen has over 27 years of professional experience in clinical data strategies. He is a frequent presenter at industry conferences and is considered to be an expert in the field of clinical data strategies. Mr. Cohen has authored numerous bylines on the topics of data standardization and technology integration. He is also the co-founder and president of the Philadelphia SAS User’s Group (PhilaSUG) as well as a founding member of the Delaware Valley CDISC User Network.

Fred Wood

Vice President, Data Standards Consulting

Fred is one of the principal contributors to the SDTM, and was the primary editor for v3.1.2 of the SDTM Implementation Guide. He is the team lead for the CDISC Submission Data Standards (SDS) Team, a former team co-lead, and a founding team member. Fred has also had a leadership role on the SEND (Standards for the Exchange of Nonclinical Data) Team since its inception in 2002, serving as a co-lead through 2008. He remains on the SEND Leadership Team, supporting domains for general toxicology, reproductive toxicology, and safety pharmacology. Other CDISC involvement includes membership on the CDISC Technical Leadership Committee and involvement in numerous SDS subteams for PK data, device data, pharmacogenomics data, and mapping the SDTM to BRIDG. Fred is also involved with the PhRMA SDTM Implementation Group and the HL7 RCRIM Technical Committee.

Prior to joining Octagon in 2006, Fred was the Global Data Standards Manager for Procter & Gamble Pharmaceuticals, a position he held for eight years. Earlier in his career at P&G, he was a toxicologist in the areas of health care (OTC and Rx) and food additives. Fred has a B.S. in Biology from Springfield College, and M.S. and Ph.D. degrees in Biochemistry from the University of Massachusetts at Amherst.

Brian C. Shilling

Senior Manager, Clinical Programming

Brian C. Shilling is a Senior Manager of Clinical Programming at Octagon Research Solutions, Inc. where he manages a team of SAS programmers. He has over two decades of experience in the pharmaceutical industry with a primary focus on ADaM, CDISC standards and validation. Brian is a current member of the Pharmaceutical SAS Users Group (PharmaSUG) Executive Committee and will be serving as Operations Chairperson at the 2011 conference in Nashville, TN. Brian is an adjunct faculty member at both Philadelphia and Arcadia Universities and co-author of the SAS Press publication “Validating Clinical Trial Data Reporting with SAS”.

Eileen Burns

Director, Biostatistics

Eileen Burns, Ph.D., M.A. has been Director of Biostatistics at Octagon for over one year. She is currently overseeing all phases of statistical activities of the biostatistics team, allocating and managing resources for each project. She provides strategy and leadership for all statistical functions, mentoring and training staff, maintaining timelines, implementing QC strategies, and developing SOPs and Guidelines, SAP templates, etc. She has written and reviewed statistical analysis plans, protocols, etc., served as statistician on Data Safety Monitoring Boards, and provided expert guidance to clients regarding regulatory issues and strategies.

Her education and experience includes earning her Ph.D. in Statistics from University of Pennsylvania and her Masters in Experimental Psychology from Bryn Mawr College. She brings 25 years of clinical research experience to Octagon, having served as a statistical leader at Wyeth Pharmaceuticals, MDS Pharma Services, University of Pennsylvania School of Medicine, Philadelphia Geriatric Center, Medical College of Pennsylvania, etc.

Her therapeutic experience includes Diabetes, Renal Disease, Hemodialysis procedures, Kidney transplant, Stroke, Depression, Anxiety, Oncology, Asthma, ADHD, Alzheimer’s Disease, Smoking Exposure, Quality of Life, Genomics, Women’s Health, ADHD, Wound Healing, VOD, Cardiovascular, and others.