• • data management
• medical device

o Data Management organizational structure and job descriptions
o Hardware and software evaluation, acquisition, and validation
o Generation and implementation of standard operating procedures
o Productive and expedient data flow

• Review and selection of Data Management equipment and service providers; negotiation of Data Management contracts

• Selection of data collection methodology utilizing “best fit” technology specific to the criteria of the project trial

• Preparation and/or review of Data Management documentation to include any or all of the following: Data Management Plan (DMP), Quality Control Plan, Edit (validation) Specifications Document, Clinical Data Review Manual, Data Management QC (quality control) Checklists, Data Management Project Binder

•Project Setup and Project Management to guarantee quality and on-time deliverables of accurate and complete databases, analyses, and reports

• Critical review of Protocol and Case Report Form design to optimize accurate and timely data collection, database setup, and data management, statistical and reporting activities

• Definition, creation, and maintenance of validated standardized data collection and data cleaning systems

• Design and creation of chemical compound and/or program data repositories suitable for the conduct of Integrated Statistical Summaries (ISS)

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ClinDatrix, Inc.
6 Jenner Street Suite 200
Irvine, CA 92618
tel. 949.428.6600 fax 949.428.1239