Leveraging our domain expertise, technology leadership, strong delivery skills and global scale, we provide the following:

We provide services around the implementation of enterprise and cloud solutions to transform the Life Sciences value chain. We lead strategy, design, implementation and deployment of transformative solutions around RIM, QMS, Clinical Data Management, Digital Health, and Safety Data Management. We also provide the following key services around large transformation efforts:

Regulatory Transformation

  • RIM Strategy
  • End-to-End RIM Business Processes
  • RIM Solution Selection
  • RIM Integration
  • RIM Data Migration and Quality Monitoring
  • Document Management
  • Submission Planning
  • Change Management

Clinical Trial Acceleration

  • eTMF
  • Integrated Clinical Data Warehouse
  • Automated Patient Safety Narratives
  • AI/ML for Medical Affairs

User Experience Design

  • User Experience Assessment of Applications
  • User Experience Strategy
  • User Experience Design and Implementation

IDMP Implementation

  • IDMP Gap Analysis
  • IDMP Business Case Development
  • IDMP Business Process Design
  • IDMP Solution Selection
  • IDMP Solution Implementation
  • Documents to Data Extraction

Quality Transformation

  • End-to-End Quality Business Processes
  • QMS Technology Selection
  • QMS Implementation
  • QMS Data Migration
  • Change Management

Cloud Enablement

  • Cloud Assessment
  • Cloud Strategy
  • Cloud Implementation
  • Cloud Managed Services

Regulatory Intelligence

Application Modernization

  • Business Transformation
  • Robotic Process Automation

Software Development Transformation

  • Agile Methodology
  • Modernizing DevOps
  • Testing Automation

Business Process Design

We partner with clients to design new business processes or re-design processes to bring efficiencies, eliminate waste and bring value to the end users. We employ techniques such as Lean Sigma and other methodologies to streamline business processes.

Business Analysis

We provide strong business analysis by leading workshops to gather user requirements, map out business processes, document user and functional requirements and support corresponding testing efforts. We follow established approaches such as Project Management Book of Knowledge (PMBOK) to capture requirements in a structured manner.  Our business analysts understand criticality of validation requirements, too.

Application Development/Integration

We excel in the design, development, deployment, and integration of large-scale digital transformation solutions for Life Sciences based on a variety of technologies and platforms. Our team is well-versed in a variety of methodologies with both on-shore and off-shore delivery models.

Validation & Migration

We bring in years of experience in validation and testing of regulated applications. At the same time, however, validation should not be a surrogate for good software development practices; we are pragmatic and thoughtful about what types of applications and scenarios need validation versus those that need proper software quality assurance.

We also bring in our expertise performing large-scale migrations using well-established techniques and tools, both around data and content migration.

Change Management & Training

Any major digital transformation initiative requires carrying a multitude of stakeholders across the transformation journey, increasing the need for adoption of new processes and systems. Strong change management initiatives are important right from the beginning of transformation initiatives through implementation and post-deployment of new systems and processes. Engaging with end-users is critical to ensure continued use and adoption of new tools.  It is important to share and communicate the “what” and “why” of changes that are being envisioned, followed by the “how” through training. Engaging in strong change management efforts right from the planning stage of a transformation initiative to implementation and post-implementation is therefore critical.

Data Quality & Governance

Data quality and data governance processes are key to data utilization in order to make better decisions and improve efficiencies. It is important to ensure there is adequate governance around information management so that the quality of data is maintained high. Then, there are enough organizational resources to capture, curate and maintain such high quality data.  We are knowledgeable in data unification, using platforms such as Tamr and master data implementations, while companies prepare for RIM and IDMP implementations.

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