Our team has vast experience in the Healthcare & Life Sciences industry, leading digital transformations and change management projects, and delivering thoughtful and insightful solutions.
Our team has extensive experience in designing and implementing transformative digital products on various platforms including Salesforce, AWS, Microsoft Azure and Google Cloud.
Clinical Data Management
Consulting (strategic program planning, protocol review, EDC selection, etc.)
Case Report Form (CRF) design utilizing the most up to date SDTM implementation guides
Database design, development, and maintenance
Data validation programming and testing, inclusive of edit check and manual review specifications
Data entry, if applicable
Data cleaning and query management
Medical coding using WHODrug & MedDRA dictionaries
Serious adverse event (SAE) reconciliation
Management and integration of local laboratory reference ranges with CRF data
Integration, verification and reconciliation of external electronic data
EDC selection and end-user training
Database lock and archival
Triage of all initial and follow-up source documentation to ensure criteria for a reportable case(s) are met and review for accuracy and completeness
Assignment of case numbers to all new SAEs
Obtaining the causality assessment from the medical monitor within 24 hours
Communication with site(s) to obtain all supporting documentation (ex. Discharge summaries, autopsy reports, laboratory and diagnostics reports, etc)
Drafting of safety narrative(s) according to ICH guidance encompassing medically relevant information and query the site for additional or discrepant information
Completion of MedWatch/CIOMS forms
Provision of Global Submission of SUSARs to regulatory agencies
ICSR Safety case management (End to End)
Medical & Scientific Report writing
Adverse Event follow-up Management
Audits and Inspection management
QMS, GXP, and Validation
Our validation services are designed to be highly flexible and scalable, ranging from an advisory level of support to providing a full turn-key validation. We start by making sure we have a complete understanding of your specific needs and only finish after ensuring these needs have been met through extensive testing and documentation.
With deep industry expertise and a passion for delivering exceptional customer experiences, Cereblis enables companies to take advantage of innovation in tech by onboarding new ways to work and execute projects by advising, implementing, and optimizing digital solutions.
4320 Winfield Road, Suite 200
Warrenville, IL 60555 USA
Phone: +1 (312)-763-8040
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© Cereblis 2020