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Clinical Trial Management
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Data Management
Data Management
Full Service Data Management:
BIOTECH Consultancy Services can meet a wide variety of data management needs. We structure the study and reporting to accomodate your preferences and methodology. Our data management capabilities include, but are not limited to:
Data entry (within two working days)
Data quality assurance (including creation of edit checks)
Adverse event / medication coding
Case Report Form design
Creation (including all database elements, derivations and edit check creation)
Database testing to study initiation
Testers for database validation
Initial queries (within five days of receipt of casebooks)
We offer expertise in Oracle Clinical and experience in ClinTrial, SAS and other major database systmes used for clinical trials.
Data Entry
Our experienced data entry staff is highly proficient and accurate in double-key case report form (CRF) data entry.
Quality Assurance
We are committed to excellence and dedicated to providing our clients with accurate, quality databases.
Dictionary Coding
We provide our clients with standardized coding utilizing the Thesaurus Management System (TMS) of Oracle Clinical.
CRF Design & Presentation
We aid the sponsors, investigators, site managers, and clinical research associates in reaching their goals for reporting complete and accurate data.
Database Design
We work as a team with our clients in the design, development, review and implementation of quality Oracle. Clinical databases across all phases of clinical studies.
Data Audits
Our experienced auditors adhere to well established, proven auditing practices, utilizing a methodical exam and review of programmed data listings tailored to meet our clients' needs.
Other Services
With our connection to Makro, one of the most respected staffing firms in the industry, there is no service we cannot provide.
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