Advancement allows for clinical research data in agency-required format and the ability to
conduct full-service projects in house.
Toronto, ON October 24, 2013
Inflamax Research Inc., a full-service Contract Research Organization (CRO) specializing in Proof of Concept as well as Phase I through IV studies in allergy, asthma, ocular, and dermatology utilizing EEC technology is pleased to announce expansion of their e-Source Clinical Data Management (CDM) services.
The CDM team has experience with electronic data capture services, having built, released, and “locked” 375 databases since 2006 in multiple study designs and therapeutic areas. All team members are members of the Society for Clinical Data Management (SCDM) and all have achieved their Certified Clinical Data Manager (CCDM) status. The utilization of CDISC and CDASH standards provides the industry-standard data exchange models which facilitates submission for FDA requirements. In addition to a full complement of data management services, including web-based fully compliant 21 CFR Part 11 electronic data capture capability via secure Internet access, Inflamax Research Inc. has integrated its e-Source data capture in the clinic seamlessly into good data management practices. This includes Inflamax Research Inc.’s electronic Patient Data Acquisition Tablet (ePDAT™) in which patient-reported outcomes are input directly and then captured securely and directly into the database.
“Having a full-service CDM department allows Inflamax Research Inc. to offer, in addition to their clinical expertise and novel mobile Environmental Exposure Chamber (mEECTM) technology, the ability to provide clinical research data in agency-required format for potential submissions. This is a definite plus for those clients who want a cohesive service provider for their clinical trials”, states Denise Redkar-Brown, Inflamax Research Inc.’s Senior Director of Clinical Data Management.
“The addition of our fully-integrated e-Source data management services adds the ability to have full- service projects in house, but the teams’ experience in stand-alone clinical data management services allows Inflamax Research Inc. to expand our offerings to include that as well,” adds Derek Johnson, Director of Data Management for Inflamax Research Inc.
“I am excited to launch our fully-integrated e-Source data management services here at Inflamax Research Inc. This is only possible due to our strong data management expertise and leadership that we have here at Inflamax Research Inc. where we are truly developing state-of-the-art data management tools. Clinical safety and efficacy data management is core to a successful clinical trial. Our CDM experts will be involved early on in discussions about data collection options and will oversee the development of data collection tools based on the clinical trial protocol working closely with our sponsors. Inflamax Research Inc.’s CDM offerings will integrate seamlessly with our electronic data acquisition capabilities in the EEC and field in our multicenter trials, as well as provide standalone CDM services for those clients who require them, ” states Dr. Anne Marie Salapatek, President and Chief Scientific Officer of Inflamax Research Inc.
About the Inflamax Research Inc. CDM Team Leadership
Denise G. Redkar-Brown, Senior Director for Clinical Data Management, has over 25 years of experience in pharmacology and clinical research having worked on multiple compounds/vaccines that have been submitted and approved by the FDA. Presently, Denise is a trustee on the Society for Clinical Data Management (SCDM) Board of Trustees, chair of the SCDM On-line Learning Committee and facilitates multiple on-line courses for SCDM. In addition to scientific papers that appeared in journals such as The European Journal of Pharmacology and Prostaglandins, Denise has been published in the Good Clinical Practices Journal in April 2008 for her article “From Process to Project”, discussing the evolution of the Clinical Data Manager’s role in clinical research.
Derek Johnson, Director, Data Management is a Certified Clinical Data Manager (CCDM) through the Society for Clinical Data Management (SCDM) and has been overseeing Data Management operations for more than five years. During this time he has managed more than 350 eDC studies in phases I – IV, including specialization in Allergies (Environmental Exposure Chamber), First in Human, Drug Interaction, Dermatology and Thorough QT trials. In addition to his clinical data management experience, Derek brings 10+ years of management experience and extensive CDISC SDTM and CDASH experience. He has been involved in the submission of over 135 CDISC SDTM submissions. In 2011, he was invited to present at the Society for Clinical Data Management (SCDM) annual conference, “Hurdles Facing Early Phase CDM Utilizing eDC”.
Both Derek and Denise have been selected as Subject Matter Experts (SME) for the SCDM’s Good Clinical Data Management Practices (GCDMP) new chapter on Electronic Data Capture. The GCDMP which was awarded the Good Clinical Practice Journal (GCPJ) Award for “Most Successful Company or Program of the Year in Raising GCP Standards” in London (2007) is the current industry standard for clinical data management that consist of best business practices and acceptable regulatory standards.