Indegene is a leading technology-driven solutions provider pioneering in streamlining clinical trials and offering exceptional clinical data management for a seamless clinical trial experience. Indegene measures its success in terms of number of satisfied customers and believes that all aspects of clinical programming including data management, data analytics, and eCRFs solutions must stem out from a customer's perspective. Catering to the varied study needs of big- and small-scale customers, Indegene is hands-on on nearly 1000 trials including 400 oncology trials.
Indegene is present globally and offers a flexible engagement model to support the trial needs of customers worldwide. Having worked on industry's top EDC technology solutions, such as Medidata Rave, Medrio, Merge, InForm, and OpenClinica, Indegene is deemed capable of foreseeing and providing consultancy on the best solutions for all its customers. Indegene is a Medidata Rave-accredited partner and utilizes its capabilities to extend its clinical trial services in a broad range of therapeutic areas. Our proprietary technology solutions which work with core clinical vendor solutions have helped our customers achieve shortened timelines for completing trials, random data availability, maximized efficiencies, and reduced trial costs.
Indegene's solution and delivery team consists of domain experts, data scientists, and global IT professionals with extensive experience in their respective domains. Our people are certified into specific areas of expertise and ensure that your study gets nurtured in an environment of dedication and expertise. Technically sound, Indegene has a scalable infrastructure and a 24/7 support environment to support your business round-the-clock. Indegene strictly adheres to all the approved industry standards in all its offerings.
We have a large talent pool of life sciences postgraduate and technology professionals trained and experienced in clinical data management services and solutions and with extensive knowledge of various therapy areas and regulatory requirements. We have professionals with MD and PhD degrees with in-depth medical and therapy area knowledge, respectively. We also have professionals with postgraduate degree in science to perform data review and data cleaning.
As a multiyear recipient of Great Places to Work® awards, Indegene is ideally positioned for access to high-quality talent as an employer of choice at premier medical and life sciences institutions and through lateral internal hiring opportunities. We leverage an enterprise-wide internal learning and development academy to ensure ongoing knowledge and ongoing performance management systems to maximize retention.
Indegene is an ISO 27001:2016 and ISO 9001:2015 certified company and we provide knowledge processing services for global pharmaceutical and healthcare organizations. Indegene has well-defined and best-in-class program/project management practices certified by CMMI Level 3 for Services, which help us deliver projects more efficiently in terms of quality and timelines, thereby driving high level of client satisfactions. A robust quality culture is established and practiced across our teams. Our process and quality management plan are compliant with the global and regional regulations/guidelines. With ISO- and CMMI services-based quality frameworks, both Process Quality Assurance and Product/Service Quality Control are ensured across all customer engagements.
We deploy dedicated program management office to oversee quality, training, and infrastructure to increase organizational responsiveness, promote knowledge retention, and share best practices. The benefits to our clients include:
Minimal client "hand-holding"
Minimal investment of time and efforts in training and reviewing
Minimal time to get started and ramp-up
Indegene has extensively invested in harnessing modern technologies (artificial intelligence, machine learning, etc.) to positively impact the traditional services and processes, including pharmacovigilance. With a dedicated innovation team (Technology experts, Product Development, Data Scientists, Analysts, Annotators, and Subject Matter Experts), Indegene has a robust framework in place to address contentious issues faced by life sciences organizations. This enables us to offer solutions led by advanced medical expertise ably supported by technology-driven automation and productivity.
Multisite Presence: With footprints across the globe, Indegene goes beyond geographical and cultural barriers to build the study setup of customers, irrespective of caste, ethnicity, language, or culture.
Transparent Management Processes: Indegene believes in keeping its operations customer centric and welcomes customer involvement at all stages of study development. Going by industry's best practices, we finalize the data development requirements with a sign-off from customers. We maintain regular communication with customers to discuss data management project milestones and the overall project progress.
Flexible Engagement Model: Indegene's right sourcing model is in synch with the trending times and takes into consideration the process, technology, budget, and time-related requirements of customers. We are technically capable of helping the customers decide upon the right tools and technologies and offer consistent and reliable data services in a broad spectrum of therapeutic areas. Our technically sound domain experts counter the therapeutic challenges and data management-related operational issues with ease and ensure research data integrity for a seamless customer experience.
Robust Infrastructure: Indegene is well equipped with various tools, technologies, and setup to cater to the data needs of customers globally. With a scalable setup, competitive expertise, strategic partnerships, and industry-specific certifications to its credit, Indegene is geared up to handle large and complex trials of clinical giants or the start-ups. In case of IT failure scenarios, we work on eliminating the scope of losing your precious data with our strong IT infrastructure. We understand that issues can arise anytime, and so, we make ourselves available for the customers round-the-clock.
Our Project Management team manages the entire project life cycle beginning with investing effort in a direction-oriented project kickoff. A sound database is the foundation of a steady online study process, and so, our dedicated Database Design team keeps a dedicated focus to optimize your database build, as per the requirements. Our approach to this involves integrating with the customers to refine data requirements, designing CRFs strategically to incorporate participant information, ensuring edit checks, providing custom functions, accommodating data integrations, performing data migrations, and keeping a scope for mid-study protocol amendments. As an additional security measure, we implement Rave Safety gateway (RSG) in our solutions. Our project data managers maintain coordination with the database designers and ensure all support documentation exists, user requirements are incorporated, industry standards are met, and the protocol definition synchs with the live study system.
As data is the most crucial aspect of any study, the role of data managers in clinical trials is of utmost importance. Data managers at Indegene own the responsibility of setting up and monitoring clinical trials. To ensure the validity, completeness, consistency, and efficacy of clinical data, our data managers focus on deciding apt data collection mechanisms based on the protocol. At operational level, our data managers are responsible for finalizing the database lock, whereas at a corporate level, they contribute to helping the customers derive on strategic decision-making. Further, to ensure fool-proof clinical data, our CDAs and data managers are actively involved in performing a quality check on the data with precision, attention, and carefulness to ensure that the data entered in eCRFs are consistent, error-free, and not duplicated.
Refer to our PoV on Indegene PM DM.
Best Practices: We deliver solutions that are strictly within the boundaries of domestic and global regulations including adherence to FDA, CSIDC, and 21 CFR Part 11 e-signatures. In terms of application of domain knowledge, our domain-specific global talent incorporates its knowledge in all areas of clinical development. Be it defining and refining the data requirements, CRF designing, process building, data integration, or study amendments, we bank upon our domain knowledge and experience to come up with viable study solutions.
Indegene provides EDC services in a host of technologies. Although Indegene is a Medidata-accredited partner, this partnership does not limit our capabilities in supporting the data needs of customers on various other technologies such as Medrio, Merge, OpenClinica, and InForm. Our reporting mechanism for clinical data utilizes the capabilities of various technologies such as JReview, Crystal Reports, SAS, and Comprehend. Facilitating our EDC services as a thin client application, we are already on the way to harness the power of cloud for simplicity, flexibility, and value addition in the form of savings on infrastructure setup and maintenance costs.
The eClinical systems are complex and the scope of operational issues among customers cannot be ruled out. To minimize such nagging issues, Indegene considers it imperative to educate the customers about using the system. Indegene also takes a step ahead in helping the customers understand the importance of EDC services and how it can enrich the customers' clinical trial experience multifold.
Refer to our White Paper on Data Management.
The fact of the matter is that the clinical trials arena is governed by the term “Change.” To be wise on that part, Indegene provides ample scope for data migration, integration, and mid-study protocol amendments to its customers.
|Trial Start-up: Final Protocol to FPI||Trial Conduct: FPI to Database Lock||Trial Close: Database Lock to Final Report|
|Protocol Review||Data Review and Discrepancy Management||Reporting and SAS Programming|
|CRF Design||External Data Integration||Safety and Efficacy Programming and Analysis|
|Specifications Development||SAE Reconciliation||Trial Reporting|
|Trial Setup||Medical Coding||CSR Audits|
|Trial Testing||Remote Data Coordination||eSubmission Ready Data|
|Data Management Plan|
|Blended Learning and Training Solutions|
|Global Library Development and CDISC Consulting|
|Process Assessment and SOP Development Consulting|
Minimally Invasive Spinal Fracture Management and Repair
Medical Devices (Other Than Spine)
tXdesigner | FASTER BUILD, BETTER CONTROL: Our tool for the automated study design
Specify forms, fields, folders, visit schedule, and edit checks
Import from existing ALS
Visual assembly from existing studies and standards
Import Rave Architect Loader Spreadsheet
Design Case Report Forms
Design Edit Checks/Data Validations
Design Visit Schedule/Trial Road Map
Design From Global Library
Create and Track Test Scripts
Track Programming Completion
Publish Design to ODM/Rave
Audit Trial/System Logs
Collect data from different sources.
Data enrichment and storage
Data normalized in the Hadoop setup
Perform data mining and analysis
Data analyzed and presented in visually rich format for the timely decision-making
Indegene has been providing onsite consulting services to the leading sponsors on a short-term to long-term basis.
Consult and drive the implementation of clinical IT solutions to further strengthen information integration and data analytics capabilities
Manage consulting and requirements management regarding technology areas and process optimization in close collaboration with business teams and project teams
Design and analyze clinical system architectures
Conduct technical planning, design, and implementation of project working packages regarding architectural aspects
Manage the selection and implementation of state-of-the-art IT solutions including exchange-to-exchange (E2E) responsibility for solutions' operability
Ensure system integrity and stability across changes applied to the respective application cluster and interfaces to other process streams
Develop, manage, and maintain an enterprise integration strategy and road map.
Initiate and help implementing emerging digital health technologies, mHealth, IoMT etc.
Indegene has the industry's top-notch consultants/statisticians to provide advanced programming that solutions improves efficiencies, which are obtained from single or multiple studies using onsite models.
Statistical analysis plans
Integrated summaries for safety and efficacy
Tables, figures, and listings
Randomization code generations
Statistical and clinical study reports