Clinical Data Management Services
Driving decision-making and mitigating risks through timely access to accurate data
Clinical research data is the final product of your study. It determines whether your study’s primary and secondary endpoints have been achieved and supports the regulatory approval of your investigational product for commercialization and distribution. It is crucial to the success of your study that your data are accurately generated, analyzed, and managed by an expert data management team.
Accurate data collection and robust clinical data management will:
Ensure that the Study Protocol is faithfully translated into data endpoints
Allow for proactive and informed decision-making throughout the lifecycle of the study
Increase the trust of regulators, publishers and investors in your data
Do you know what data collection platform is most suitable for the scope and budget of your study?
These objectives can only be achieved if the data is collected in the appropriate format, is well organized and properly annotated. This is why the development of a clear and detailed Data Management Plan is essential to collect, clean and organize data with efficiency and integrity.
Our Clinical Data Management Services
In order to maximize the quality and integrity of your study data, our biotech CRO offers data collection, management, and reporting services for your study from its conception until database closure. By having access to your study dashboard, using industry-compliant advanced graphics and data visualization technology for clear, accurate, transparent data reporting, you can have the assurance of accessing the necessary information to make the right decision at the right time.
Data Collection
- Electronic case report forms (eCRF)
- Paper case report forms (CRF)
- Electronic diaries
- Electronic participant reported outcomes (PRO)
Data Management
- Fully-developed Data Management Plan
- Fully-validated and documented database and programming
- Data clarifications (DCF) management
- SAE reconciliation
- Medical coding (MedDRA & WHODD)
- Data quality control
- Centralized data monitoring
- Data transfers
- Laboratory and third-party data imports
- SOP development and review
- Pre-FDA auditing
Data Reporting
- Screening/enrollment status
- CRF status
- Study product inventory
- Adverse events (AEs)
- Protocol deviations
- Unanticipated problems
- Primary/secondary outcomes
- Data queries
- 24/7 access to live reports of study activities
Our Data Management Approach
At ethica, we understand that data drives decision-making. Our clinical data management processes and practices have been developed to allow you to access your study data in a timely and organized fashion so that potential issues that may harm research participants or compromise your study’s performance can be rapidly identified.
Our Data Management Procedures
At ethica CRO, we are dedicated to maximizing the integrity of your study data. Our extensively trained data management team will guide you in the selection of a data collection platform most suitable for the scope and budget of your study. All of our data management software meets the industry’s highest standards and is 21 CFR Part 11 compliant. Small study with a tight budget? We can still use paper CRFs!
Training and information regarding study conduct and procedures will be provided to all parties during the study kick-off meeting. At this time, our team of biostatisticians and statistical programmers will introduce potential study designs and develop the Data Management Lifecycle Plan. This plan will outline all essential activities pertaining to data collection, maintenance, usage, and archival throughout the duration of your research program. The purpose of the Data Management Plan is to ensure efficient data collection, organization, and annotation, all of which are critical for achieving the objectives of your study. The development of this plan will also prevent any delays that may affect the efficiency of your research program, either due to unclear documentation, data reformatting, or organizational issues.
Our data management procedures are fully compliant with the Clinical Data Acquisition Standards Harmonization (CDASH) and Good Clinical Data Management Practices (GCDMP). ethica CRO is a Gold Member of the Clinical Data Interchange Standards Consortium (CDISC).