CLINICAL DATASOLUTIONS

2

OPERATIONAL PROCESSESAND INFRASTRUCTURE

EXTENDED ENTERPRISE FOR FUTURE REGULATORY, SAFETY, MEDICAL

Modern Technology Solutionsfor improvement in

Productivity and QualityMedical/Regulatory

expertise at Scale

Clinical DataSolutions

Global ProductLabelling andArtwork

Digital MedicalEngagementSolutions

PromotionalMedical Review

Pharmacovigilanceand Drug Safety

Arti�cial intelligence enabled digital CDM and trial accelerator platform

AI-enabled end-to-end pharmacovigilance and drug safety operations

Multi-country execution to drive compliance and productivity

Simpli�ed, faster and more e�cient promotional/medical review and copy approval solutions

Technology platforms and services for digital and virtual MSL engagement with HCPs and patients

STRONG, ROBUST, SCALABLE, FLEXIBLE OPERATING MODELS

7 global delivery centres across Americas, India and China

Data centres across the US, Latin America, India and China

Delivery andData Centres

Local client servicing support

In 50 countries across the US, Europe and Asia

Regulatory and local market understanding

Local ClientSupport

Digital, mobility and medical centers in LA and Montreal, Canada

Innovation�Hubs

ISO 9001 and 27001

HIPPA compliant

QualityManagement

3

MEDICAL SOLUTIONSSTRADDLING THE LIFECYCLE

R&D, Clinical, Regulatory, Safety, Labeling, Medical Affairs

Medical Customer Engagement Layer

Pharmacovigilance and Drug Safety

Regulatory Affairs

Clinical Data Management

Medical Affairs

Drug Discovery and Preclinical Development

Phase – II Clinical Trial

Post Marketing Surveillance and

Commercialization

Phase – III Clinical Trial

Phase – I Clinical Trial

AE Case Intake and Case Processing

Medical Writing, Aggregate Reporting

Signal detection and Risk Management Services

Regulatory Intelligence,

Pipeline Analytics

Regulatory Information Management

Clinical Trial Disclosure

Regulatory Dossierand Label Creation

Publishing andSubmission

Medical Monitoring

Social MediaListening

Clinical Programming and Biostatistics

Risk Based Monitoring

Medical Coding and Writing

Physician Engagement

Medical Communications

Medical Review and Compliance Services

Study Specs Management and Build Setup

4

END-TO-ENDCLINICAL DATA SOLUTIONS

Trial Start-up Trial Conduct Trial Closure

FirstPatient In

Last PatientLast Visit

ProtocolDevelopment

Database Lockand Medical

Writing

Indegene Proprietary Technologies and Analytics

Risk-BasedMonitoring

AdvancedAnalytics

ArtificialIntelligence

Third-Party Technologies and Analytics

IVRS Data WarehouseEDC Labs

smartClinical Trial Xccelerator

5

PRODUCTSUITE

Our experience and insights on thousands of trials across therapeutic areas have been

leveraged to create an artificial intelligence enabled platform – TxSmart. By integrating

TxSmart with Medidata RAVE and ODM compliant EDC platforms our clinical experts have

been delivering faster, and high-quality trial at a fraction of the industry average cost.

smartClinical Trial Xccelerator

engage

Collaboration Hub

Patient Engagement and Informed Consent

• SOP management• Training• Compliance• Self-paced learning• Training assessment

• Patient education• Consent tracking

designerStudy Build Lifescience Management

• Specifications• Unit tests• Functional tests• UATs• Test data

collaborator

• Communicate• Collaborate• Collate• Coordinate• Anticipate

12

34

5

Visual Planner

• Planning playbooks• Visual milestones• Resource loading

planner

SOPs and Training

learn

6

CLINICALDATA SERVICE

M.E.D.I.C.S

EEDC BUILD, SUPPORT,

AND MID-STUDY CHANGES

Optimizedtrial design

DDATA ANALYSIS

AND MANAGEMENTData quality

and integrity

IINTEGRATIONS

Integrate data, automate tasks,and aggregate data points

CCLINICAL

PROGRAMMING

SAS, R, Business Objects andSpotfire Metrics, Datasets

and listings

SSOLUTIONS

CONSULTINGTechnology-enabledclinical data solutions

MMEDICAL WRITING

AND CODINGDictionaries: MedDRA and

WHO-DD Coding: RAVE Auto-Coder, TMS,

and DS Navigator

7

THERAPEUTICAREA EXPERTISE

5OO+�PhDs, medicine,

pharmacologists, and other life science graduates/

postgraduates

5OOO+�Years of collective

experience in safety, regulatory, medical and

clinical a�airs

Deep scalable medical expertise assisted by modern technologies (AI, NLP, ML)

ImprovedQuality

ReducedTurnaround

Time

IncreasedCompliance

ImprovedProductivity

Oncology Diabetics Cystic FibrosisCardio Vascular

Dermatology Respiratory NeurologyMedical Devices

Radiology Pain Management HIV AntiviralPsychotherapy

info@indegene.com E W www.indegene.com +1 732 750 2901P +1 732 750 7990FIndegene, 150 College Rd W, Suite 104, Princeton, NJ 08540

50% time reduction

for data

integration

>25% of wasteful investments

eliminated by

cross-study analytics

100% support

for RBM

approaches

75% reusability of pre-built

analytics saving

~15 analytics FTEs

>80% time reduction

for data

integration

OUTCOMESDELIVERED