Navigation Links
Inflamax Research, Inc. Announces Fully-Integrated Clinical e-Source Data Management Services

Toronto, ON (PRWEB) 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.

Read the full story at

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Related biology technology :

1. Inflamax Research Inc. Enters Strategic Partnership with Northern Air Environmental Technologies Inc.
2. Inflamax Research selected by the Immune Tolerance Network and the National Institutes of Health to conduct a landmark clinical study on the underlying mechanisms of allergic inflammation.
3. Inflamax Research Chosen to Conduct a Multicenter Environmental Exposure Chamber Phase 3 Study of Ultrashort Grass Allergy Vaccine by Allergy Therapeutics (UK) Ltd.
4. Inflamax Research Appoints Dr. Anne Marie Salapatek President & Chief Scientific Officer
5. Inflamax Research Introduces Electronic Patient Data Acquisition Tablet™ (ePDAT)™ for Real-Time PRO Data Collection
6. Inflamax Research announces the launch of its Mobile Environmental Exposure Chamber™ for conduct of Allergy & Asthma Trials
7. Managing Cultural Variability in PRO Measurement in Global Clinical Research, New Life Science Webinar Hosted by Xtalks
8. Medical Device and Drug Research, New Life Science Webinar Hosted by Xtalks
9. Medrio, a Leading EDC Provider for Clinical Research, Announces Its Latest Version, 8.1 with iPad Support, is Available Without Charge for Academic Researchers
10. Medrio, a Leading EDC and eClinical SaaS Provider for Clinical Research, Announces the Highly Anticipated Release of Medrio 8.1 with iPad Support
11. Preliminary Research, Led By Dr. Vincent Giampapa, Finds Aged Adult Stem Cells Can Be Functionally Reprogrammed To Act Like Younger Cells
Post Your Comments:
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf ... the 2016 USGA Green Section Award. Presented annually since 1961, the USGA Green Section ... her work with turfgrass. , Clarke, of Iselin, N.J., is an extension ...
(Date:11/24/2015)... ... 2015 , ... Copper is an essential micronutrient that all ... copper is also toxic to cells. With a $1.3 million award from the ... a systematic study of copper in the bacteria Pseudomonas aeruginosa (P. aeruginosa), a ...
(Date:11/24/2015)... 24, 2015 --> ... report "Oligonucleotide Synthesis Market by Product & Services (Primer, ... Diagnostic, DNA, RNAi), End-User (Research, Pharmaceutical & Biotech, Diagnostic ... the market is expected to reach USD 1,918.6 Million ... a CAGR of 10.1% during the forecast period. ...
(Date:11/24/2015)... New York , November 24, 2015 ... to a recent market research report released by Transparency ... projected to expand at a CAGR of 17.5% during ... "Non-invasive Prenatal Testing Market - Global Industry Analysis, Size, ... estimates the global non-invasive prenatal testing market to reach ...
Breaking Biology Technology:
(Date:10/29/2015)... , October 29, 2015 ... authentication company focused on the growing mobile commerce ... announces that StackCommerce, a leading marketplace to discover ... the Wocket® smart wallet on StackSocial for this ... ("NXT-ID" or the "Company"), a biometric authentication company ...
(Date:10/27/2015)... Synaptics Inc. (NASDAQ: SYNA ), the leader ... adopted the Synaptics ® ClearPad ® Series ... newest flagship smartphones, the Nexus 5X by LG and ... --> --> Synaptics works closely with ... in the joint development of next generation technologies. Together, ...
(Date:10/23/2015)... , Oct. 23, 2015 Research and Markets ... "Global Voice Recognition Biometrics Market 2015-2019" report ... --> The global voice recognition biometrics market ... --> --> ... been prepared based on an in-depth market analysis with ...
Breaking Biology News(10 mins):