Clinical Research is crucial in the study of drugs that are supposed to reach the market right from pre-clinical through all the phases I- IV. Being subject to regulatory compliance it is indispensable for them to have flawless processes and data with high level of integrity in place.
QuaLIS Clinical Trial Management App collection helps the industry right from pre-clinical through all the phases of clinical trial management. The solution includes a clinical LIS for volunteer screening and testing. InterFACER the clinical instrument interface middleware is deployed for interfacing clinical instruments.
A volunteer database management system including biometric identification and screening handles the volunteers for clinical studies. A study protocol configuration module helps in creating studies. A dynamic user modifiable CRF module helps in creating various templates for study recording. Phlebotomy, dietary, vitals recording, sample processing and storage are completely handled by the system.
The Bio-availability/Bio-Equivalence (BA/BE) module handles the receipt of sample into storage freezers. Studies are conducted on the samples on LC-MS, ICP-MS, HPLCand UPLC with automated preparation of sequences for such instruments. Receiving validated results from instruments through the ELN is a highlight of our solution.
QuaLIS® Clinical Research Highlights
- Volunteer database management with biometric identification
- Volunteer screening
- Clinical Pathology LIS
- InterFACER® middleware for clinical instrument interface
- Protocol generation of schedule
- Protocol document creation & management
- Conducting and recording (phlebotomy, dietary, vitals, CRF)
- 21 CFR Part 11 compliance
- Sample storage & shipping
- Sample receipt in BA/BE lab.
- Batch creation for LC-MS or other instruments
- ELN based results capture, review, validation and approval
BA/ BE LIMS
Clinical research organizations conducting bioavailability and bioequivalence studies are highly regulated.
QuaLIS Method Development App
A Method development and validation app were developed in QuaLIS platform to assist analytical R&D to prepare the final method validation reports quite efficiently.
Method Development Projects
The system allows running several method development projects simultaneously. The trials conducted for each project can be recorded meticulously. The ultimate method trial that will go for the validation is narrowed after the method validation trials are completed.
Method Validation & Reporting
It is possible to create templates for generation of final method validation reports in MS-Word and dynamically insert method validation results into such templates. This helps a lot in time-saving and at the same time tools like Word are very comfortable to work.
The final validation report can contain several 100s of pages of the report that will include the final validation report with test results of validation and supporting details such as instrument raw-data are automatically printed along with these reports. On an average, it saves more than 50% of the time in preparing such reports.
- Keep track of your method development trials in a controlled manner
- Save more than 50% time in preparing your method validation reports
Analytical Method Development laboratories can use this solution to achieve compliance and operational excellence Clinical trials are sets of tests in medical research and drug development that generate safety and efficacy data about adverse drug reactions and adverse effects of other treatments for health interventions. Biotechnology and pharmaceutical industries along with clinical research institutions need to manage large amounts of data involved with the operation of a clinical trial. It maintains and manages the planning, preparation, performance, and reporting of clinical trials with emphasis on keeping the up-to-date contact information of participants and tracking deadlines and milestones such as those for regulatory approval or progress reports.
QuaLIS CTMS provides a comprehensive solution for Volunteer management, Screening management for a frequent update of volunteer status and preparation for Study management. CTMS manages the Protocol preparation and approval, Study planning and Case Record Form (CRF) generation, Clinical Trials for Participants and tracking deadlines and milestones. Management of Pharmacy and other stock ensures smooth operations and a seamless process.
Configurable Checklists and Study Protocols
Checklist required for various types of studies can be configured and maintained with version control. Protocol with study pattern for Dosage, Catering, Phlebotomy and Vital signs can be prepared with ease using the automated scheduler.
Typical Workflows Pharmacy Management
- Storage locations can be defined and managed for trial pharmacy products
- Storage condition logs can be maintained
- Tracking of Entry / Exit to Storage Chamber
- Product consumption transaction logs along with Study association
- Volunteer records can be added, edited and deleted
- Volunteer identification using biometric scan throughout project cycle
- Block / Retire volunteer based on validation criteria
- Search / Filter volunteer records based on study requirements
- Associate additional volunteer information and documents
Protocol and Study
- Define screening and study checklists
- Define Protocol with Dosage, Catering, Phlebotomy and Vital signs schedules
- Record study details with deviation against schedule time
- Generate study summary and regulatory reports
- Reduce paper and storage space – Systematic workflow management and status updates for each step
- Pharmacy and Stock management for uninterrupted study and traceability – Schedule management with deviation recording against schedule time
- Improved Regulatory compliance – Controlled access with ease of data search
- Easy of data analysis and reporting – Adverse drug reaction and adverse effects reporting with controlled investigation
The web-based solution can be accessed through any browser