Clinical Trial Services
Data Management
The data management staff has extensive experience in all areas of data management, including data collection tool design, database design and development, query management, coding, SAE reconciliation, and EDC data management.
HCRI is dedicated to providing creative data management solutions to the pharmaceutical, biotechnology and medical device community. Our Data Management staff has extensive experience in all areas of data management, including: data collection tool design, database design and development, query management, coding, SAE reconciliation, and EDC data management. HCRI Data Management works closely with the project team from the proposal process through post-database lock to produce a high-quality database deliverable within specified timelines. During the design phase, HCRI Data Management will work with the sponsor to create a project-specific, efficient data management process that adheres to our standard processes. Our objective is to deliver a clean, locked database with a minimal error rate within agreed-upon timelines.
First and foremost, our Data Managers are committed to providing you with high-quality data through efficient, streamlined data management processes. The Data Manager assigned to your project will work through these processes with your approval of critical deliverables. Whatever your data needs may be, our project team adds its experience, creativity and commitment to manage and deliver results that help you meet your clinical objectives.
Our qualified Data Management staff has the knowledge and experience to quickly initiate a study, deliver a quality-tested database, and effectively manage data to achieve results within an expected timeframe. The staff receives targeted training in the specific clinical areas to which they are assigned. HCRI Data Management adds value to the study team by bringing its wide range of experience to a variety of therapeutic areas, including oncology, central nervous system (CNS), anti-infectives, gastroenterology, internal medicine, and cardiology.
HCRI Data Management relies on adherence to FDA's 21 CFR Part 11 and ICH-GCP guidelines to meet our regulatory requirements. Our network environment has been qualified, and our clinical data management system, including EDC, has been tested and validated with well-documented procedures.
HCRI Data Management services include:
Key advantages of utilizing HCRI Data Management
First and foremost, our Data Managers are committed to providing you with high-quality data through efficient, streamlined data management processes. The Data Manager assigned to your project will work through these processes with your approval of critical deliverables. Whatever your data needs may be, our project team adds its experience, creativity and commitment to manage and deliver results that help you meet your clinical objectives.
Our qualified Data Management staff has the knowledge and experience to quickly initiate a study, deliver a quality-tested database, and effectively manage data to achieve results within an expected timeframe. The staff receives targeted training in the specific clinical areas to which they are assigned. HCRI Data Management adds value to the study team by bringing its wide range of experience to a variety of therapeutic areas, including oncology, central nervous system (CNS), anti-infectives, gastroenterology, internal medicine, and cardiology.
HCRI Data Management relies on adherence to FDA's 21 CFR Part 11 and ICH-GCP guidelines to meet our regulatory requirements. Our network environment has been qualified, and our clinical data management system, including EDC, has been tested and validated with well-documented procedures.
HCRI Data Management services include:
- Paper or electronic case report form (CRF) design;
- CRF tracking;
- Clintrial® (paper-based CRF) or Inform® (electronic CRF) database design and build;
- Data entry and verification for paper studies and special EDC projects;
- Data Management Plan (DMP) development and maintenance;
- Data validation programming for Clintrial or Inform projects;
- Programming and query management for projects that are Clintrial-based, Inform-based, or within an EDC system of your choice;
- Medical coding of adverse events and medications;
- SAE reconciliation of the clinical database to the safety database, and
- Generation of data listings, status reports, and metrics
Key advantages of utilizing HCRI Data Management
- Experienced, professional data management personnel with expertise in medical device, biotechnology, and pharmaceutical therapeutic areas
- Demonstrated flexibility to using paper- or EDC-based systems
- Demonstrated flexibility to using either our internal EDC system or one of your choice
- Well-documented and well-maintained Data Management Plans
- Annotated data collection tools that leverage standards and gain efficiency
- Manual data review by experienced Data Managers
- Automated CRF and query tracking
- Automated edit check programming procedures
- Thorough user acceptance testing (UAT) for EDC studies
- Thorough testing of paper-based databases
- Strong, motivated project teams
