Our team has over 10 years of experience in delivering expert data management and biostatistics solutions. We offer a full range of clinical data management and biostatistics services utilizing internal teams as well as long-established, trusted alliance partners from the European Union and USA. The use of internal as well as outsourced resources ensures that Cromos Pharma is able to deploy the very best in niche capabilities on a study by study basis.
Experienced in all phases of clinical trials (Bioequivalence studies, Phase I-IV, Postmarketing (Observational) Studies) and registries (Interventional and Non-interventional), in wide range of therapeutical areas
Experienced in the most popular EDC systems such as Oracle Clinical, Medidata Rave, Medrio, Viedoc, Marvin, RedCAP, Castor, MedNET, OpenClinica (ClinCapture
Study-specific Database setup and update (if required) based on eCRF/ECM specifications.
Central monitoring using data analysis software like SAS, R, SQL-based apps.
Full cycle of Data Management and Biostatistics documents workflow in terms of:
Study-specific validation package,
Data Management Plan,
eCRF and edit checks (ECM) specifications,
Data Validation Plan,
Account Management, Data Transfer, Data Import and Database Freeze/Lock procedures,
Data Review Meetings Report/Minutes as well as Interim/Final Clean File,
Randomization Specification and Randomization Schema,
Statistical Analysis Plan incl. TFLs shells (Data Display Plan),
Statistical Analysis Report,
Statistical Programming Validation procedure, etc.
Case Report Form (CRF) development/validation.
Accomplish different randomization approaches like blind/unblind procedures without or with any number of stratification criteria
Query Management based on implemented automatic edit checks, manual data review, summarized data central monitoring
Semi-automatic Data Coding using MedDRA and WHO-DRUG dictionaries
Data Reconciliation with External Sources (Safety Data Reconciliation with PV Database, ePRO data reconciliation, etc.)
Biostatistical service oversight in terms of sample size calculation, statistical planning and reporting, SAS programming (TFLs, SDTM and ADaM datasets)
Clinical Trial Data Management
If you are interested in outsourcing clinical data management and biostatistics services, please contact our Business Development team by emailing firstname.lastname@example.org.