Our strong team of Data Managers designs, builds, and deploys clinical databases that exceed industry standards in regards to timelines and quality, while ensuring that your clinical trial data is managed with precision and accuracy.
Our extensive library of CRFs/eCRFs expedites the database building process, while technology allows us to easily duplicate studies, and leverage CRFs from one study to the next. This results in cost effective data management, faster time to database go-live, a functioning and intuitive clinical database, expedited database lock, and ultimately, accurate and clean data.
Efficient eCRF Setup and Simple Technical Requirements
- Simple and flexible deployment of eCRFs in multiple local languages
- Fully customizable user roles and query workflow
- Comprehensive and flexible reporting tool
- Fully compliant with FDA 21 CFR part 11
Our Data Managers have over 15 years of experience, on average, and have played a key role in multiple trials. We use industry leading software packages designed for both electronic data capture (EDC) and paper-based data capture, which allow us to be intimately involved in building clinical databases. In fact, the Data Manager who built the database is often the one who cleans the data, providing you with one point of contact for all data management activities.
Electronic Data Capture: A Cost-effective e-Solution for your Clinical Research Program
Electronic Data Capture (EDC) enables site staff and clinical monitors to capture data with greater accuracy. It allows you to have quick and remote access to data and a robust reporting library to manage your trials more effectively.
In addition, time from first patient enrolled in a study to database lock is significantly decreased by streamlining the data validation process and automating query resolution.
Data Management Technologies Available
- Medrio’s eClinical™: Provides the features expected in an EDC system, with additional integrated modules for patient reported outcomes, such as e-diaries, and randomization of patients, to further streamline data management processes.
The eClinical™ system contains completely configurable role-based security that is entirely managed in-house by Algorithme Pharma. It allows access to specific individuals depending on their function, with only a view on the data required for the individual to fulfill their role and responsibilities.
A complete range of Clinical Data Management services:
- Case Report Form (CRF) design utilizing CDASH standards
- Database design, programming, and maintenance
- Data validation programming and testing
- CRFs annotated to CDASH standard
- Data entry with experienced data entry staff
- Data cleaning and query management
- Data management status reports
- Medical coding using the WHO Drug Dictionary Enhanced and MedDRA dictionaries
- Management of external data received from specialized vendors (e.g. Central Laboratory, ECG, PK, PD)
- Medical review, computerized edit checks and queries management
- Serious adverse event (SAE) reconciliation
- Integration and verification of external electronic data
- CRF/eCRF completion end user training
- Database QC, protocol deviations listing
- Data review meeting, Database lock
- Data transfer based on sponsor specifications (ASCII, SAS®)