Services
Your Experts in Local Lab Data Management
Whether you need a one time solution or long term ongoing service, we can create something custom for your organization and needs. Please review our below list of services and contact us today. We’re here to help!
Data Cleaning
Whether ongoing regular data reviews or one time look before deliverables or database lock, we will review your local lab data to ensure it is clean and ready for FDA or other agency submission. Our clinical lab experience helps us root out data entry errors, normal range abnormalities, and inappropriately reported units of measure. You can trust our expertise to ensure quality clean local lab data.
Audit Review
Concerned about an upcoming FDA or other regulatory audit? Want to use our service for a mock inspection? Our team will ensure your local lab data follows regulations and is ready to muster up to in-depth audits and reviews.
LOINC Guidance
If you want to adhere to FDA recommendations and submit local lab data with LOINC, we can review and ensure LOINC completion and compliance. We can provide recommended LOINC for data that needs an associated code.
Protocol Review
We will review your protocol and ensure that all local lab particulars are appropriate and clear for your CRO or Data Management team. We can ensure that the forms, validation manuals, completion guidelines, and data all comply with the protocol.
Ongoing Trial SDV
Clinical team members and trial coordinators are overwhelmingly busy with other trial procedures. They are likely missing key validation of the source data vs what is entered in your CDMS. We will perform source data verifications to ensure local lab data, normal ranges, and other important data matches from source to EDC.
Database Setup & Start-up Assistance
Need assistance designing local lab forms? Need help translating the protocol language into workable CRF’s? Are your data managers unable to decipher needs for your local lab data? We can consult on appropriate form design and other key database set-up ideas to streamline your trial, reducing the need for database modifications.
Review of Validation Manuals
Clear validation manuals and form completion guidelines are of the upmost importance for smooth clinical trials. Consult with us to ensure your guidance documents are concise and relevant to your study local lab build.
Edit Check Evaluation
Edit Checks and System Queries can greatly improve trial management reducing the need for sites and data managers to manually review and query data. Our team can review your study’s edits and ensure their use is maximized. We will review test requirements and feasibility as well as perform risk assessments.
User Access Testing (UAT)
Want to ensure thorough and robust testing of your local lab forms? Our team can perform UAT on your trial’s local lab forms to ensure complete workability.
Listing Builds
Our team can assist with listing builds including specification review for protocol and validation manual compatibility. We will ensure your listings are built right the first time so data managers can maximize their effectiveness in reviewing local lab data.
FDA 1572 Compliance
We will review your study’s list of local labs and ensure all 1572 forms are completed correctly.
