Transforming Clinical Operations Globally
An evolving healthcare landscape has pushed enterprises around the world to improve their clinical operations.
An evolving healthcare landscape has pushed enterprises around the world to improve their clinical operation systems.
Providing high-quality healthcare is paramount in today’s day and age. We are witnessing healthcare systems trying to streamline workflows, improve business efficiency, and scale exponentially to ensure the outcomes we desire.
Smart IMS has crafted clinical operations services focused on optimizing organizational efficiency. Our aim ranges from enhancing clinical trial processes to implementing real-time insights and patient-centric care.
Our Holistic Clinical Operations Services
Embark on a transformative journey towards better healthcare delivery.
Clinical Trial Management System (CTMS)
Create systems to ensure managing and tracking clinical research activities within your research group – helping it serve as a single, centralized, web based or on-premise resource center used to manage all clinical research
Core functions implemented:
- Trial scheduling and setup
- Regulatory Approvals Tracking
- Managing study financials and billing compliance
- Integrate with external operational and data systems
- Amendment tracking
- Real time access to study documents and subject activities
- Standardize billing process
- Robust data and reporting functionality
Electronic Trial Master File (eTMF)
Set up systems which enables managing of all clinical trial processes and documents in one system, in real-time, as they are executed, offering precision planning and intelligent automation, and reducing manual efforts and risks. Critical for Good Clinical Practice (GCP).
Core functions implemented:
- Easy setup and managing of study design that meets SOPs
- Allowing remote collaboration and data collection
- Allowing scalability and real time transparency to collection process
- Quick use of templates
- Secure storage and archival means
- Supporting standards and conventions through quality control workflows
Electronic Data Capture (EDC)
Build systems to help record and manage research data through standardized data forms, workflow rules and logic to verify quality of data and reporting metrics for real time progress tracking
Core functions implemented:
- Participant profiling
- Customizing data forms and workflows
- Out of box CRF templates based on CDISC standards
- Setting up data access and role privileges
- Providing full audit trail capabilities to meet regulatory compliance
- Query monitoring and research data from site
- Schedule configurations
- Real time data reports
- Communication systems supporting teams across the globe
Electronic Clinical Outcome Assessment (eCOA
Get strategy and assistance in building, setting up and managing systems to ensure real time data, provide concise insights and help ramp up overall study efficiency assuring smoother patient experience
Core functions implemented:
- Data collection schedule management
- Remote, device agnostic medical outcome information collection and electronic diaries
- Participant end point assessments
Randomization and Trial Supply Management (RTSM)
Build systems to streamline randomization, stratification and inventory management processes in clinical trials, manage stratification, perform different randomization types, manage medicine supply, track stock and patient history, integrating with other clinical trial systems and ensuring transparency through real-time reporting.
Core functions implemented:
- Randomization type design
- Ensuring clinical and operational support
- Real time tracking and data capture
- Rapid deployment and implementation
- Enabling direct to patient medication provision
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Meet Our Industry Leaders
Executive Vice President – Life Sciences & EAM
Dr. Rahul Srivastava is responsible for Strategy, execution, and P&L for the Life Sciences portfolio at Smart IMS, focusing on technology solutions and services for CROs, AROs, Pharma, life sciences, and regulators.
Dr. Srivastava is coming with over 25 years of experience in technology implementation in life sciences and dental sciences. As a thought leader, he carries a business-oriented consulting experience to help the client in the process re-engineering and building cost-sensitive and robust technology solutions.
Dr. Srivastava has been a part of various IT governance and steering committees involving CIOs and CTOs of client organizations to advise on product strategy, and IT TCO analysis for capital budgeting, planning, governance, and partnership selection.
Dr. Srivastava is a published author, trainer, and a coach.
Director
Dr. Ritesh has over 19 years of experience working with CRO, Healthcare IT, BPO and Government Organizations. He is leading the development of the Life Sciences Product portfolio and solutions.
Dr. Ritesh comes with a blend of technology and Domain expertise and has worked on various functions including Service Delivery Operations and Subject Matter expertise for Pharmacovigilance, Clinical Data Management and Healthcare Product development. Ritesh also comes with experience of implementation of Electronic Health Record Application and providing leadership for implementation of Government schemes at State level.
Director
Dr. Alex Philip is a Technologist and Product Strategist with extensive expertise in Lifesciences – Clinical Trials, and Healthcare, in both the Providers and Payers space.
He is a trained Physician with prior clinical experience and has nearly two decades of experience in developing solutions for Clinical Operations, Clinical Data Management, Electronic Trial Master Files, Electronic Health Records, and Payer Systems. As a subject matter expert, he has executed several successful product strategies to develop solutions that meet customer needs and drive business growth.
Dr. Philip is passionate about leveraging technology to improve patient outcomes and has specific expertise in Healthcare Interoperability and Systems Integration. With his strong background in Product Development, Product Design, Technical Architecture, and Business Analysis, he is well-versed in identifying and implementing emerging technology trends and their potential impact on the market.
Dr. Philip’s unique blend of medical expertise and technology allows him to innovate and improve healthcare delivery.
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