- In-house database design and programming
- Manual and automated data validation on entered data. Our review focuses on typical issues with pain trials, such as rescue medication versus pain intensity and typical analgesic adverse events.
- Medical coding
- Electronic Case Report Form (eCRF) design using an internal template library of pain CRFs for streamlined build approach
- Rapid EDC development, implementation and management
- CDISC Study Data Tabulation Model (SDTM)
- Conversion services
- Online access to the system
- Custom reports tailored to each individual trial
- Management of third-party data (e.g. lab, pharmacokinetics [PK])
- Data cleaning, including query management and report/listings review
- Standard set of reports tailored to pain trials
- Serious Adverse Event (SAE) reconciliation
EDC & Data Management
Lotus Clinical Research’s databases are Part 11 and Clinical Data Interchange Standards Consortium (CDISC) compliant with audit trail and other key quality features.
Lotus Clinical Research Data Management processes are designed to provide standards for how work will be completed yet offer the flexibility to customize our support for the needs of your study. Our goal is to ensure your data quality through well-designed data collection, data cleaning, and data management.
We have specialized teams that support either early development studies or later phase studies. Our EDS teams are accustomed to the fast cohort-based studies often found in Phase 1 and 2 studies. These studies often require cohort-based safety reviews to allow the study to proceed to the next cohort. We have the experience and processes needed to quickly clean the data and provide custom reports for the safety reviews.
Data Management Plan (DMP)
Lotus Clinical Research utilizes in-house developed templates as a starting place to customize and elaborate the details for your study. The DMP is intended to discuss all things data-related, spanning from database development through data lock and study archive. Lotus Clinical Research will version-control the document, but the DMP is also intended to be a “living” document throughout the duration of the study.
Data Quality Review Plan
Lotus Clinical Research develops a data quality review plan specific to the needs of each study. This plan defines data review being conducted beyond the CDMS data checks. The defined reviews utilizing data extracts and reports are supported by a set of smart listings. These smart listings have been developed to support two goals, data quality, and efficiency. They support ongoing data review by keeping track of the study teams review and flagging any changes to previously reviewed records. This eliminates the inefficiencies of having to manually keep track of previous records and increases quality because any data modifications are identified, and another review is initiated.
Lotus Clinical Research staff are trained to build and support databases in the Veeva EDC system. Understanding the type of data collection necessary may be equal to or more important than the scope or size of the study. Our DM team will collaborate with the study team through each step of database development, starting with a review of form specifications and once developed an online form review will be conducted. We take the time to review the forms with site personnel to provide a chance to suggest changes that would ease data entry. This step, which is not done by most CROs, helps promote data being entered correctly the first time. Once the forms are approved, we will add field level data checks and field and form skip logic.
Lotus has trained EDC developers to support both the initial build and any mid-study changes. Based on our experience, having internal builders helps us maintain the flexibility and efficiencies needed to not compromise quality when we need to release updates quickly. All data checks and skip logic will be tested, by Lotus during our UAT step. Your study team is offered the opportunity to also perform user acceptance testing (UAT) on the database.
Lotus provides support for all studies with data entry guidelines available for online training to help site staff should the need arise. We also support the training of all study team members and can customize training needs by role or training format. Investigator meetings hosted presentations and pre-recorded training videos are some ways training may be supported at your preference.
Data Metrics & Reporting
Lotus generates a significant number of data metrics, data cleaning, and data review reports daily. All these reports are stored in a repository that is available to the entire study team. This will allow all users to see the status of the entry and cleaning, without the need to request and wait for the information.
Our team supports medical coding using the MedDRA (by unique terms) and WHO Drug Global (by unique medication, indication, route, and country) dictionaries. Terms are coded within Veeva CDMS utilizing the coding module. These dictionaries are updated twice a year, and if needed our team can support up-versioning all of the coding to the newer version.