Advancement allows for clinical research data in agency-required format and the ability to conduct full-service projects in house.
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.