CEO & Chairman, Jim Walker of Octagon Research Solutions, Inc., a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the appointment of Ms. Mary Lenzen and Dr. Frederick Wood as principal consultants in Octagon’s Clinical Data Strategies division. In their new roles, Ms. Lenzen and Dr. Wood will oversee CDISC training initiatives and spearhead the company’s broader efforts to continue building on its leadership position in CDISC conversions, training, and thought leadership worldwide, reaffirming its commitment to the highest levels of data standards professionalism and support.
Octagon Research Solutions, Inc. is a proud corporate sponsor of CDISC (Clinical Data Interchange Standards Consortium), a collaborative working group made up of representatives from industry and the FDA. CDISC’s mission is to lead the development and support of global, platform-independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.
“Mary and Fred are an unparalleled set of assets to provide training and consulting on CDISC standards and initiatives,” stated Tom Guinter, vice president of Clinical Data Strategies, “No other company has this breadth of knowledge, resources, and tools to help the industry adopt these standards. CDISC is on a real growth track and I am excited that Mary and Fred have chosen to be part of the Octagon team.“
Both Mary and Fred have been members of the CDISC Submission Data Standards (SDS) Team since its inception in 1999, and have served as Team Co-Chairs for the past four years. The SDS Team produced the Study Data Tabulation Model (SDTM), and in 2005 received the Leveraging/Collaboration Award from the FDA ‘For creation of the standard Study Data Tabulation Model (SDTM) and accompanying implementation guide for submission of data tabulation datasets.’ Mary and Fred are members of the Standards Review Board, a leadership team within CDISC that has the responsibility for reviewing and approving any changes or enhancements to SDTM.
Ms. Lenzen most recently was the leader of global Clinical Data Standards at Pfizer, Inc., where she managed and led technical staff to support data standards for clinical data encompassing the clinical trial process from development through marketed drugs. Ms. Lenzen has almost 30 years of pharmaceutical industry experience combined with a Master’s degree in Computer Science. In addition, she is a key contributor for the CDISC controlled terminology initiative. While at Pfizer, she represented Pfizer on the CDISC Industry Advisory Board.
Dr. Wood was most recently global data standards manager, Clinical Data & Information Management, at Procter & Gamble Pharmaceuticals, where he led efforts to develop company-wide data standards. His CDISC involvement also includes membership on the CDISC Production Standards Coordinating Committee and the CDISC Industry Advisory Board. Dr. Wood has also had a leadership role on the CDISC SEND (Standards for the Exchange of Nonclinical Data) Team.
During his tenure at Procter & Gamble Pharmaceuticals, Mr. Wood received numerous awards and citations including the CDISC Outstanding Achievement Award for the Submission Data Standards (SDS) Team in 2000 and 2004, and for the SEND Team in 2004 and 2005.
“Today’s appointments demonstrate our ability to attract the industry’s best and brightest talent, and reaffirm our commitment to creating and providing the most innovative suite of services backed by industry-leading training and leading edge technologies,” added Jim Walker.
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through cross-functional electronic submission expertise, a holistic process approach, deep domain knowledge, and integrated solutions. Octagon is headquartered in Wayne, PA, with offices in Boston, MA; Costa Mesa, CA; and European headquarters in Amersham, UK.