Global Research Protocol Registration System
Today’s drug discovery research and development operation in bio-pharmaceutical companies requires creating, managing, executing thousands of in-vitro and in-vivo screening, assays through traditional or high throughput systems involving chemistry, genomics, bio-markers, animals and human subject. All of these activities are carried out collaboratively by company scientists, license partners, academic researchers and CROs. An example of research logistics challenge for a global biopharmaceutical R&D organization:
- 15 million compounds
- 300,000 people
- 34,000 registries/protocols
This creates an enormous logistics challenge for global research and development organization. Inefficiencies persists with home-grown solutions due to complex navigation and massive data entry requirements.
Xybion Protocol Registry Platform, built on Xybion’s Digital Acceleration Platform, is a single, cloud-based Digital Laboratory and Workplace solution for all of your Protocol Registration needs for High Throughput Screens (HTS), ADME, Panel Screening (internal and external panels), preclinical studies, SAR, In-Vivo studies and for managing chemistry processes. The process rules, security, faceted search capability, powerful query builder and report capabilities of the solution allow the customer to retrieve the data from downstream applications at the right time by the appropriate people, which can include partners, external service providers, and other stakeholders via secured solution and mobile platforms.
Scientist now can utilize a single solution to manage all their protocol metadata and resulting protocol documents promoting transparency, accuracy, efficiency and the ability to detect trends.
- Able to manage all the protocol metadata and resulting documents
- Able to promote transparency, accuracy, efficiency and the ability to detect trends
- Reduce redundant data entry due to frequent updating of master data through integration with downstream sources
- Improve collaboration between internal and external stakeholders, enhancing productivity and compliance
The solution includes:
- Purpose-built Dashboards with tasks, favorites, charts, and lists based on role.
- Powerful and configurable searches over the metadata and drawn chemistry structures/reactions.
- Protocol creation and metadata collection – various unique numbering schemes for auto-generated IDs and granular security for the scientist team.
- Experimental (Test) Parameter Set logging – allows collecting all of the various types of experimental data that will be used in the protocol from the Media to the experimental conditions
- For subject-based studies/screens – the creation and collection of groups, subjects, treatments, and dosing metadata with the relation between them
- Search protocol documents globally using simple and faceted searches
- Flexible workflow allows the capability to utilize one common workflow for the collection of data across widely different screen types; providing only the relevant fields per each type within the workflows
- Both push and pull automated integrations with Active Directory and the customer’s RIF system for master code set values, project data, target data, metadata, and critical flags
- Record lifecycle statuses triggered by permission-based actions, with approval tasks, versioning of metadata and report and locking of editing.
- Ability to group parameter sets for downstream statistical analysis. Auto protocol document creation based on the metadata, including an onscreen preview and Word protocol generation
- Migration of legacy data/records
- Creation of new protocol records from imports
- Record copying capability at the Protocol level and parameter level to reduce time to initialize a new protocol with similar values
- Bulk change capability to allow changes over multiple records
In addition, the solution is also being used to manage Chemistry Protocols, including the recording of single or multi-step reactions. The chemistry group is using the chemistry protocol workflow to:
- Draw chemical structures associated with the protocol at both the summary and the reaction step level
- Search the chemistry protocols at the Reaction summary and individual step level by their chemical structures
- Creation of protocol documents based on the entered metadata in PDF format
- Add tags to the records to accommodate the multiple ways of referring to studies and compounds
- Monomer search integration to external system to pull monomer data