Intelligroup Value to Pharmaceutical Customers
Shorten the Drug/Product Development Life Cycle |
| |
- A CDISC compliant solution for managing the creation, review, approval and overall management of Clinical Protocols. This solution helps reduce the "start to approve" time to complete the protocol, enabled by collaborative reviews and approvals with Part 11 compliant E - Signatures
- Use of Supply Chain Planning and Execution Core of Tier 1 ERP Solutions to manage clinical supplies while supporting kit level traceability, integration with kit randomization, IVR triggered shipments, blinding of treatment arms, lot release status for each country etc. This helps you achieve more on time and accurate shipments and a reduced overage.
- Solution for creating time phased forecasts for the patient kits to be shipped to sites and countries covering the initial seeding and replenishment. This forecast is based on study design, countries, labeling plan, projected enrolment rates, number of population, titration and other key parameters.
- Custom built solution for creation of site shipment triggers and shipment requests based on supply parameters for optimum management of the limited inventory of kits, both at sites and depots.
- Collaborative solution for creation, translation, approvals and overall management of Label Text for Clinical Labels, to help reduce the time taken for label text management
- And others...
Effectively Manage End-to-End Supply Chain for your Products
- Deploying collaborative and end to end supply chain planning and execution tools for an accurate forecast of the demand, a full supply plan (including CMOs and Procurement), recoding of execution details, tracking the actual vs. plan, GMP Compliance and overall management of your supplies through out your extended supply chain.
- Setup your ERP Solution to enable real time capture of batch data, comparison against the Master Batch Record and capture deviations and dispositions to create a complete electronic batch records, integrated with MES where required
- Setup your ERP solution to help manage you distribution and sales (as the case may be) through Third Party Logistics providers, by providing a platform for daily data exchange (both to and from 3PLs) for Sales Orders Entered, Shipments to be made (along with specific lot assignments), shipments completed, invoices raised etc.
- Setup your ERP solution to help manage your supplies through your contract manufacturing operations via a portal for entry at source, or upload of data, with a view to maintain visibility into inventory movements, schedule changes and impacts on upstream and downstream schedules; and also for lot traceability
- Help Integrate the transit temperature data loggers with Shipment Solutions (where data loggers provide for the feasibility) to setup the shipment related information into the data logger, and also building the shipment and excursion history for analytics.
- Implementation of ePedigree solutions
- And others...
Reach out to Consumers and Influencers Effectively
-
Building. publishing and maintaining healthcare portals targeted towards physicians and healthcare providers to help them with relevant information like medical information databases, R&D Content and services and brand content.
- Solutions for on line samples ordering by physicians with the required controls
- Integration with and presentation of call effectiveness tools
- Building of Sales Analytics tools on the prescription data used for targeted messaging
- And others...
Enhance Systems Quality and Compliance
-
Comprehensive assessments of GMP / QSR Compliance status your ERP and other systems and a well defined roadmap recommendations for achieving optimal compliance
- Risk Based GAMP5 Guidelines driven, right sized and faster Computer Systems validation for our or other implementations using our highly adaptable and reusable Validation artifacts templates
- Comprehensive 21 CFR Part 11 Assessments for your ERP and Other systems
- Best Practice driven Testing Plans, Test Scripts Development and Execution; and Defect Management based on the Best in Class Software Tools available for Requirements Management through to Test Management to complete the traceability of tests to requirements
- Consulting on overall IT Governance and development of IT related SOPs.
- And others...
|
| |
 |
| |