Tech mahindra
Tech mahindra

Research and Development

Our Life Sciences practice offers innovative solutions for effectively managing drug discovery and development processes. The solutions enable and enhance the drug discovery and development cycle by improving productivity while reducing the cost and time to market.

  • Discovery Informatics

    We offer the following services:

    • Identification of the disease target by using Bio-informatics tools and databases in P. Falciparum for Malaria
    • Identification of the target by using Bio-informatics sequence analysis tools in Tuberculosis
    • Identification of the gene expression for human brain disorders using hierarchical clustering techniques
    • Study the activity of physicochemical descriptors of the molecules in terms of quantitative structure activity relationships by using Artificial Neural Networks (ANN)
  • Pre-Clinical

    Our pre-clinical service offerings include data integration, analysis and reporting services for  pre-clinical business functions. These functions include protocol management, animal management, pathology management and toxicology data analysis. The services enable organizations to make informed decisions and move to clinical development.

  • Clinical Trial, Data and Supplies Management

    Our Integrated Clinical Development Platform (ICDP), Clinical xPress, is built on the foundation of Oracle Health Sciences (OHS) applications for the Healthcare and Life Sciences industry.

    The solution helps organizations to reduce the total cost of ownership (TCO) on IT investments. The solutions simplify the process of procuring Oracle Clinical and Remote Data Capture software, set up a study and conduct a trial.

    The offering on clinical supplies management addresses the issue of maintaining accountability of drugs undergoing clinical trials for Life Sciences organizations. The offering enables faster, easier and better tracking of clinical supplies and reduces the regulatory non-compliance issues.

    We leveraged the relationship with Siebel and implemented the eClinical module for Johnson & Johnson for efficient management of clinical trials, regions, sites and subjects.

    The implementation improved clinical trial effectiveness, reduced drug development cycle time, eliminated dependency on disparate legacy systems and reduced cost.

    Data Standardization – Capabilities:

    • Feasibility study for data standardization
    • Business case preparation for implementing CDISC standards
    • Translation of protocol into ODM, SDTM ready data elements
    • Custom solutions for conversion to CDISC standards
    • CDISC conformance audit on existing systems / tools/ standards
    • CDISC compliant tool selection
    • Interoperability analysis using ODM and LAB standards
    • Conversion of existing CDMS, CTMS systems to be CDISC compliant
    • Preparation of SDTM compliant data sets
    • Preparation of CRT data sets
    • Preparation of Define.pdf and Define.xml for submission

    Standards

    • Submissions Data Tabulation Model (SDTM)
    • Analysis Data Model (ADAM)
    • Operational Data Model (ODM)
    • Laboratory Data Model (LAB)
    • The Standard for Exchange of Non Clinical Data (SEND)
    • Clinical Data Acquisition Standards Harmonization (CDASH)
    • The Biomedical Research Integrated Domain Group (BRIDG)

    Document Management Services:

    • Design/ Implementation of Enterprise Document Management Solutions
    • Integration of different Document Management Solutions for CDMS
    • Integration of LAB and ECG data from multiple sites
    • CRF Data Conversion to documents
    • Configuration/ Administration
    • Lifecycle Management
    • Document Workflow Management Services
    • Docket Preparation (local and global)

    Solutions

    • Documentum, Open Text and Adobe Solutions
    • Integration of existing Clinical Data Management Systems to Enterprise Document Management Systems
    • Enhancements of existing Clinical Data Management System
  • Clinical Safety

    Our services on the Argus Safety application for Life Sciences industry enable managing risks that ensures safety during the clinical trials and post-market studies.

    Pharmacovigilance:

    • Adverse Event Reporting Systems Integration
    • Patient Safety and Surveillance
    • Coding – MedDRA, SNOMed
    • CIOMS Integration
    • Product Safety Update Reporting
    • WHO / COSTART integration

    Solutions

    • ARGUS/AERS Systems Configuration and Integration
    • CIOMS and Regulatory Reporting
    • Safety and Surveillance – Maintenance / Custom Built applications
    • COTS Tool Selection and Implementation
    • Enterprise Content Management / Data Mining Configuration and Implementation
  • Regulatory Submissions

    • Regulatory Affairs Strategy, Lifecycle & Development is a broad term. It runs the gamut from Strategy, Submissions Planning, Content Authoring, Component Coordination, Assembly, Publishing, Internal Review, Dispatch and Archiving. Viewed from the perspective of Regulatory Information Management, it is even broader bringing other related processes such as Registration Management, Labeling Management, Health Authority Correspondence, Commitment Tracking, and Regulatory Intelligence into consideration. For now, most Regulatory Affairs organizations have focused on those activities falling within the Regulatory Operations area.

    • Regulatory Affairs plays a critical role throughout healthcare product lifecycle, from concept through product obsolescence. It provides Strategic, Tactical and Operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the globe.

    • The following Hub & Spoke model represents the way we currently operate for Regulatory Dossier Compilation and Strategy.

    • Drug Portfolio Management

      Our services on Drug Portfolio Management for the Life Sciences industry enable managing new product development projects and research activities. Portfolio Management for new products combines many approaches to prioritize and select projects to maximize value, align to strategic goals, maintain the right balance and optimize resource usage.

  • Clinical Data Management

    Our Clinical Data Management (CDM) system offers complete data management solutions for Life Sciences industry.

    The system accelerates and streamlines the process of clinical trial study while ensuring regulatory compliance to current Good Clinical Practice (cGCP).

    Tech Mahindra’s Clinical Data Management Solutions have the following features

    • Backed by MSAT platform
    • Adhere to Good Clinical Data Management Principle and Clinical Data Interchange Society Consortium Standards
    • Secure Infrastructure
    • Documented Processes and SOPs
    • Trained Resources
    • Compliant with 21 CFR Part 11 Requirements
    • Based on latest Tools and Technologies
    • Quality Oriented
    • Submission Ready Solutions

    Electronic Data Capture:

    • Preparation of Data Management Plan
    • Study Setup and Configuration
    • Case Report Form(CRF) Design and Database Programming
    • Edit Check Programming
    • Data Transfers from LAB /External Systems
    • Remote Data Capture(RDC) Implementation
    • Discrepancy Management
    • Adverse Events Integration
    • Data Base Administration(DBA) Services
    • Reporting Services

    Solutions

    • Oracle RDC, Inform & Rave MediData solutions & Indigenous Tools

    Paper based Data Management:

    • Scanning the source documents and tagging the source data with electronic format
    • 21 CFR 11 Requirements Analysis
    • Preparation of Data Management Plan
    • Creation of Data Entry Screens
    • Creation of Edit Checks and Data Quality Checks
    • Tagging the data elements into CDISC compliant ODM data
    • Database Design
    • Thesaurus Integration
    • Double Data Entry
    • Verification and Validation Activities
    • Data Clarification and Query Resolution
    • Quality Control
    • Database Locking and Preparation for Submission
    • Project Management
    • DBA Services

    Solutions

    • Oracle Clinical, Clintrail & some Indigenous Tools
  • Bio Statistic Services

    Our Statistical Analysis solution enables scientists and researchers to gain faster insight and better intelligence from clinical data. One area of decision-making where significant competitive advantage can be achieved is clinical data analysis.

    The solution improves patient safety and optimizes dosages and track side effects, thereby enabling new drugs to be developed and approved more quickly.

    We developed the Statistical Analysis Software programs for Takeda, a Japanese Life Sciences organization, to convert datasets to global datasets. The conversion process went through multiple iterations of validations at the end of each cycle. The solution helped achieve global standardization of clinical trial data and reuse of components for subsequent transformation.

    Biostatistics:

    • Preparation of Statistical Analysis Plan
    • Study Design
    • Randomization Design
    • Protocol Preparation
    • Tests
    • Survival Analysis
    • Kaplan–Meier Survival Curve
    • Pearson and Spearman Correlation
    • Logistic Regression
    • Non Parametric Analysis
    • ANOVA
    • Integrated Summary of Safety /Integrated Summary of Efficiency
    • Submission Preparation

    Solutions offered

    • Based on the industry standard SAS 9 platform
  • Medical Writing

    The medium of communication across the clinical research process right from the patient to the sponsor and other stake holders involved in the clinical trial process like clinical research organizations, regulators etc should have a common understanding of the documents meant for exchange and validation. The medical writing is a science that deals with writing medical literatures in a highly communicable way as content is the key for positioning. It enables you to connect with and influence the target audience. We provide end to end medical writing services right from pre clinical, clinical development and post launch.

    Medico Marketing:

    • Monographs
    • Newsletters
    • Journal Supplements
    • Booklets
    • Leave-behinds
    • Speaker Kits
    • Poster Presentations
    • Continuous Medical Education (CME)
    • Medical Conference Coverage
    • Public Relations Material
    • Proposal Writing
    • Training Manuals
    • Product Monographs
    • Marketing Collaterals
    • Business Insight Reports
    • Commercial Abstracts of Key Scientific / Clinical / Medical Papers

    Scientific Writing:

    • Clinical Trial Summary(CSR) Reports
    • Editing Services
    • Abstracts and Journal Articles
    • Preparation of Manuscripts
    • Summary Reviews of Medical and Scientific Literature
    • Dossiers
    • Publications
    • Reviews for Publication in Medical or Scientific Journals

    Regulatory Writing:

    • Development Safety Update Reports(DSUR’s)
    • Periodic Safety Update Reports(PSUR’s)
    • Suspected Unexpected Serious Adverse Reaction (SUSAR’s)
    • Drug Master Files(DMF’s)
    • Trail Master Files(TMF’s)
    • Investigator Brochures(IB’s)
    • Protocol Writing
    • Inform Consent Forms(ICF’s)
    • Common Technical Documents(CTD/eCTD’s)
    • Clinical Trail Application(CTA), Market Authorization Application(MAA), New Drug
      Application(NDA), Annotated New Drug Application( ANDA),Supplementary New Drug
      Application(s-NDA), Investigational New Drug (IND), 510k ,Biological Application(BLA) etc
 

White Papers

Listening to Social Noise in The Pharmaceutical Space

Listening to Social Noise in The Pharmaceutical Space
For further information please write to connect@techmahindra.com

For further information please write to connect@techmahindra.com