ClinTec provides a full-service solution for Clinical Data Management and Biostatistics ensuring the delivery of high quality clinical trial data in the most cost effective way for your project.
Our Data Management specialists have many years of experience within different therapeutic areas and of managing both EDC and paper studies. Supported by the appropriate CDMS systems they ensure that your database lock is timely without sacrificing data quality.
Our Services in Data Management
|•||Data Management input during protocol development|
|•||Database design and validation|
|•||Electronic exception check programming and validation|
|•||Data Collection: Electronic Data Capture (EDC) or manual Data Entry from paper CRFs|
|•||Data Handling and data cleaning in our 21 CFR part 11 compliant CDMS, according to ICH-GCP|
|•||Ongoing QC of data including final QC prior to Database lock|
|•||Coding of medical terms (Medications, Secondary Diagnoses and Adverse Events) according to MedDRA|
|•||Ongoing Serious Adverse Event Reconciliation|
|•||Integration of third party vendor data including ECG data, Central and local laboratory data, imaging data and PK data|
|•||Transfer of high quality data for statistical analysis and submission to the regulatory authorities, according to CDISC or client specific standards|
|•||Data Management consulting/training for implementation of new systems, coding and dictionary management or creation of new Standard Operating Procedures (SOPs)|