EMPOWERED DECISION-MAKING | CLINICAL DATA MANAGEMENT
The key to patient safety and confirming efficacy in clinical development today is to capture quality clinical trial data. Our talented team of designers, developers and data managers design, build, and deploy quality clinical databases to meet timelines while ensuring that your clinical trial data is managed with precision and accuracy. Our data managers average over 15 years of experience and play a key role in your trials.
Clinical Data Management Services Tailored to Your Needs
Data management services are available on a per-project or full-time equivalent (FTE) basis, according to your needs. We can use multiple industry-leading electronic data capture (EDC) technologies suited to your requirements. We provide customized solutions and real-time, quicker access to data, which allows for faster decisions while emphasizing patient safety.
What we offer:
- Consulting
- Strategic program planning
- EDC selection
- Protocol Review and Planning
- Review protocols with data collection and analysis in mind
- Creation of data management plan (DMP) and associated documents (DVP, CCGs, DTSs)
- Database Design, Build and Launch
- Protocol-specific functional clinical database
- Utilization of CDASH and CDISC standards
- Review and comparison prior to “go-live”
- Average 4 to 6 weeks from final protocol to “go-live”
- External Vendor Data Reconciliation
- Draft data transfer specification (DTS) provided for reconciliation
- Collaboration with biostatistics throughout timelines, database build, and SAP development
- Industry-leading system for Topline and Interim Reviews
- Visualization of real-time safety data using PowerBI
- Review of drug concentration or biomarker data with interim analysis available within 72 hours of data receipt
To ensure submission readiness, we perform target validation in accordance with regulatory requirements. Our team works closely with our biostatistics department to identify the key data domains/variables and create bespoke statistical data checks in accordance with SDTM/CDISC standards.
This allows for early identification of any erroneous data, therefore minimizing any potential errors post-database lock. This, in turn, helps facilitate high-quality statistical outputs that assist the development of clinical study reports and submission packages.
Streamlined Processes for Rapid Results
Flexible and modern data collection, capture and management methods for your research data to ensure error-free and timely database locks align with the latest regulatory guidance.
Our approach is rooted in efficiency and leverages:
- Timely and Smart Processes
- Ongoing QC
- Continual process evaluation and improvement
- Integrated clinical data sources
- Expert medical coding
- Query management and resolution
- Extensive CRF/eCRF Library
- Expedited database development
- Easily duplicated studies
- Use of CRFs from one study to the next
- Efficient eCRF Setup and Simple Technical Requirements
- Simple and flexible deployment
- Fully customizable user roles and query workflow
- Comprehensive and flexible reporting tool
- Fully compliant with FDA 21 CFR part 11
Compliance of Clinical Data Management With Regulatory Requirements
The clinical trial data management process complies with strict regulatory requirements set out by both local (depending on the regulatory region) authorities and international standards. Our data management team ensures that the acquired data and procedures align with the requirements of the relevant regulatory agencies. In addition, our application and compliance of the data standards set forth by the Clinical Data Interchange Standards Consortium (CDISC) when converting clinical and metadata streamlines the regulatory review and approval process.
We competently and efficiently support our clients with dataset mapping according to SDTM standards and CDISC conversion. Our team has expertise in creating SDTM annotated case report forms (CRFs), SDTM datasets, pooled analysis datasets (ISS/ISE), ADaM analysis datasets, and data handling reports.
Our team has worked with numerous regulatory agencies, including the United States Food and Drug Administration (FDA), Health Canada, European Medicines Agency (EMA), United Kingdom MHRA, and ANVISA. Altasciences’ data management experts draw on the regulatory expertise of our organization to ensure that all aspects of clinical trial data management comply with the relevant regulatory requirements.
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Advancing your drug candidate smoothly to proof of concept is what we do best.