What is SENDIG v3.1.1 from CDISC?

All pharmaceutical companies, biotechs and contract research organizations (CROs) will soon be required to prepare data according to the CDISC formats. Sponsors will be required to use these formats by the FDA, and consequently, CROs are increasingly expected to provide study results in these formats. Working with commercial software vendors can help ease the burden of complying with evolving format standards, while also helping you leverage best practices in a GLP regulated environment. 
All pharmaceutical companies, biotechs and contract research organizations (CROs) involved in preparing nonclinical data for submission to the FDA will soon be required to prepare data according to the CDISC SENDIG v3.1.1 (Standard for Exchange of Nonclinical Data) format. Whether you are a sponsor company or a CRO, you will be required to conform to a consistent format and terminology, which will streamline inter-organizational data exchange and generally enable the FDA to compare and analyze study information, potentially accelerating the approval process and throughput, In addition to the new data format, you need to ensure that your processes continue to meet Good Laboratory Practice (GLP) and CFR-21 Part 11 regulations and that you have the documentation to prove it.  Companies will benefit from addressing the new requirements before the deadline comes into effect in December of 2016.  However, achieving compliance is not a trivial matter and may involve a significant investment in IT infrastructure and/or modifications to current business processes.
CDISC Standards Clinical Research Process

What is the Standard for Exchange of Nonclinical Data Implementation?

The Standard for Exchange of Nonclinical Data Implementation Guide (SENDIG v3.1.1) was developed by the Clinical Data Interchange Standards Consortium (CDISC).  It is intended to guide the organization, structure, and format of standard nonclinical tabulation datasets. Pharmaceutical companies and contract research organizations will soon be required to comply with SENDIG v3.1.1, which establishes certain data use and implementation standards for non-clinical datasets that are included in new drug applications and other regulatory approval documents. SENDIG v3.1.1 sets the standard for pre-clinical dataset files, containing electronic records of protocol design, animal demographics, animal exposure and animal observation data, detailing their content and terminology.

Companies and organizations submitting study data to the FDA should begin addressing the dataset requirements now, before the deadlines approach next year.

Companies and organizations submitting study data to the FDA should begin addressing the dataset requirements now, before the deadlines approach next year. These standards do not change the requirements for the design, conduct and analysis of the studies; however, gaining an understanding of the standards for data record submission and the standardization of control terminologies may well require changes in your data collection and reporting systems. Many companies are already incorporating standard terminologies into their data collection systems or are working hard to make plans to do so.
The SENDIG v3.1.1 applies to studies in single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. Work is already underway to add formats for the electronic data records of safety pharmacology and developmental and reproductive toxicology studies.
By creating a standard for submission data, CDISC SENDIG v3.1.1 is expected to streamline the communication between contract research organizations and sponsors. CROs are increasingly using these formats to send interim data sets to sponsors so that sponsors can be aware of the progress of their studies and do early analysis of the results.  More and more, sponsors are looking to CROs to provide SENDIG v3.1.1 compliant data sets to simplify the submission process. For CROs, implementing the systems and processes to produce SENDIG v3.1.1 compliant data can provide an important differentiator in a highly competitive market.

GLP and electronic data management

The data that makes up these submissions must be collected following the already established GLP and 21CFR-Part 11 regulations. The data submitted in the SENDIG v3.1.1 format must accurately represent the study setup and observations, and laboratories are required to ensure this is the case. The SENDIG v3.1.1 submission requires precise documentation of dates, times and methods followed. For this reason, it is more important than ever that your processes support these regulations and that you have the validation framework in place to prove that your processes are being followed. 
Data accuracy and workflow verification is essential in complying with increasingly stringent regulatory standards. The FDA emphasizes the importance of electronic signatures, closed systems and security features which guarantee that the management of laboratory data is tightly controlled and not susceptible to error or tampering.  In addition, conforming to a particular data standard (such as SENDIG v3.1.1) requires an on-going due diligence.  This burden can be eased by choosing a commercial software system that keeps in step with changing data format requirements.
CDISC Standards Model

How pharmaceutical companies and CROs can become SEND-compliant?

For NDA, ANDA, and certain BLA submissions, studies which start after December 18th, 2016, must have their data electronic submitted following the CDISC SENDIG v3.1.1 standards. For commercial INDs and amendments, except for submissions described in section 561 of the Federal Food, Drug, and Cosmetic Act, this is true for studies which start after December 18th, 2017.  Most companies are interpreting this as a need to be SENDIG v3.1.1 ready before the end of 2015.
Companies looking to ensure that their data management is SENDIG v3.1.1-complaint should leverage software solutions that provide data capture and assembly options out-of-the-box.  This will reduce your risk and generally help you leverage best practices, while also reducing the cost of maintaining such systems on your own.
Savante facilitates the consolidation and formatting of non-clinical data and is designed to produce SENDIG v3.1.1 compliant data submissions to the FDA from a variety of data sources (including but not limited to Xybion’s Pristima XD pre-clinical data collection system). 
Xybion’s Labwise XD is a compliance and quality management solution that works in conjunction with Savante – the company’s state-of-the-art data warehousing and SENDIG v3.1.1 data preparation tool. Labwise XD is used to organize and manage your SOPs and electronic content including SENDIG v3.1.1 datasets and non-clinical study reports.  It has modules to create a master schedule of studies, approval workflows, and to ensure you are following GLP regulations through documentation, training, and internal audits.
Xybion’s unique solutions offer advanced features that effectively bridge the gap between the business processes, animal management and scientific aspects of research absent in many of today’s pre-clinical solutions.
Xybion XDP Preconfigured Apps

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Heidi Krueger

Head of Quality Assurance

Heidi leads Xybion’s Quality Assurance practice. She has over 20 years’ experience in designing and implementing quality assurance policies. Since joining Xybion in 2000, Heidi worked with several clients to design quality policies and ensure compliance. She is responsible to hosting Xybion customer audits. Heidi has a BA degree in Biology from The King’s College.

James Castonguay

Product Technology Lead

James provides leadership to Xybion quality management systems including product design, development and client delivery. James started working with Xybion in 2002 in its Canadian division. He is now managing product delivery from the United States. James has a master’s degree in mathematics and minor in informatics from the University of Sherbrook, Quebec, Canada.

Dave Chiaramonte

Enterprise Assets and HSE Leader
Dave brings diverse and deep expertise to his leadership role as the leader of Enterprise Asset Management (EAM) and Employee Health & Safety line of business. Dave has over twenty years of experience within the Information Technology industry including development, implementation and integration of complex Enterprise Systems in large corporate environments. He is a highly regarded technology leader in IBM’s Maximo Asset Management Product implementation. Dave worked with BMS and Dupont pharmaceuticals before joining Xybion in 2004.

Tom Klapmuts

Digital Lab Solution Leader

Tom provides leadership in design, delivery and revenue growth of Xybion digital lab solutions. He is an experienced client solutions manager with a demonstrated history of working with many clients globally to solve their business problems. Tom has training in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Life Sciences, CRO Management, and Clinical Development. Before joining Xybion, Tom worked for pharmaceutical companies such as Merck and Schering Plough. Tom is a Purdue university alumnus.

Priya Rajesh

Head of Sales: APAC | Head of Operations: India

Priya is responsible for Xybion business growth in APAC region. She brings over two decades of experience in Business Consulting and Operations Management. Her deep expertise in diversified areas, including strategic alliance and partnership management, diversity and inclusivity initiatives and employee development, will amplify Xybion’s global strategic relationships and will strengthen the company’s executive leadership in India. In her last role at Conduent, she served as Director-Marketing & Bid Management. Prior to this, Priya has worked with Infosys and Covansys (now CSC). Priya holds degrees in microbiology & health management.

Raji Bijur

Head of Quality Control & CSV

Raji leads Xybion Quality Control function. She has over 22 years of experience in software quality management, CSV, SQA, software process & KPI development and industry benchmarking. She has strong process implementation knowledge including ISO, CMMI, Agile, Scrum, Six Sigma, Lean. Certified CSQA, CSV, GCP, and GAMP. Raji has led implementation of QC processes in Robotic Process Automation (RPA) projects. Before coming to Xybion in 2019, she worked with IQVIA (Former Quintiles), Infosys, Aris Global, Mphasis and serving clients across different market segments. Raji has a bachelor’s degree in information science & technology and MBA from Indian Institute of Management, Ahmedabad.

Bob Friedman

Chief Solution Architect

Bob Friedman has over 25 years of experience in Preclinical information systems at Xybion Corporation as a developer, development manager and Chief Solution Architect. He has been an active member of the CDISC SEND standards consortium for five years as well as the PhUSE / FDA Industry Collaboration. Bob has previously worked for Synthes Orthopedics, NYU Medical Center and the New York State Department of Health. He has a master’s degree in Biomedical Engineering from Rensselaer Polytechnic Institute.

Gokul Panda

Head of Platform and Product Development

Gokul is the Head of Platform and Product Development, responsible for developing new and critical platforms and products. He has over 20 years of enterprise software development in the life sciences industry and related fields. Gokul holds both a Bachelor’s Degree and Master’s Degree in Engineering from the Indian Institute of Engineering, Science, and Technology. Gokul’s unrivaled expertise in enterprise software architecture and solutions provides Xybion’s clients with leading product functionality, innovation, and platform stability.

Anu Roy

Chief Solutions Delivery Officer

Anu manages project delivery and relationship. She has over 18 years of Life Sciences industry and IT services experience. Anu has a strong track record of designing and developing digital solutions, management consulting, quality & compliance Management, CLM, process & key metrics design, program execution & improvement and account management. Anu is a recipient of the STEM WOC ‘Technology Rising Star ‘by US Women’s magazine in 2014. She has received several other awards including Infosys Consulting Architect Award for outstanding achievement in 2011, RCL Crown Golden Brain Award in 2013. Anu is a guest columnist at Pharmaceutical Compliance Monitor and published in several international business magazines. Anu has a bachelor’s degree in Biochemistry and MBA in marketing.

Keith Dempsey

Chief Information Officer

Keith Dempsey has joined Xybion as our global CIO. He brings 20+ years of progressive Information Technology experience from Merck, AIG, Barclays and PriceWaterhouse. Focusing his career on building global strategies that capitalize on progressive technologies that scale in accordance to realized business growth. His experiences range from introducing new technologies that facilitated a competitive advantage for Merck, introduced new and scalable technologies for AIG Investments, and created progressive global organizational improvements for Barclay’s Capital. Keith has a degree in Chemical Engineering from Clarkson University and an MBA from William Paterson University.

Steve Porfano

Executive Vice President & Chief Financial Officer

Steve manages Xybion corporate function which includes Finance, HR, Legal and QA. Steve joined Xybion in 1989 as Corporate Controller and was promoted to Chief Financial Officer in 1991. As Chief Financial Officer, Steve is responsible for the establishment, enhancement, coordination and administration of the Company’s financial systems, internal controls, and related areas. Additionally, he is the corporate liaison to the Company’s bank, independent certified public accounting firm and governmental compliance and financial auditors.

Kamal Biswas

President & Chief Operating Officer

Kamal joined Xybion as its President and Chief Operating Officer in 2018. He is an acknowledged leader in the life sciences industry and has over 20 years’ experience in management consulting and pharmaceutical business. Very recently, Kamal was a Partner and leader of the global Life Sciences practice at Infosys Consulting. Before that, he spent several years working with pharma companies including Novartis Pharma and Ciba Geigy to manage manufacturing and late-stage R&D functions.

Pradip K. Banerjee, Ph.D., MBA

Chairman of the Board & Chief Executive Officer

Dr. Banerjee is an entrepreneurial senior executive with 30+ years of in-depth experience in the global Life Sciences, Healthcare and Services industry in global operations, strategic management, business development, investments and new ventures creation, M&A and Buy-outs. Prior to acquiring Xybion in 2008, Pradip served as President and CEO of Science Center in Philadelphia focused on creating, incubating, managing and investing in science based new companies. He was the Partner-in-Charge of the pharmaceutical Research & Development unit of Accenture where he created the R&D consulting unit and had grown it to become $100+ million worldwide business. Dr. Banerjee holds a Ph.D. in Pharmaceutical Sciences from University of Wisconsin-Madison and an MBA from the Wharton Business School of University of Pennsylvania.

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