CORPORATE PROFILE

ABOUT US

01 Fervor is the first customer-centric CRO

02 Founded by expert dedicated to advancing medical science.

03 Fervarriors strategically balance

Science

Patient

Clinical Development

Data Analytics

ABOUT US

Global fullservice CRO

providingintegrated

services

Global CRO

HighlyExperiencedTeam withExtensive

Knowledge

Experience

4 Continents,6 Countries, 8

Officesacross the world

Outreach

ImpeccableRegulatory

track records

Regulatory Expertise

Always Auditand Inspection

Ready

Quality

GLOBAL PRESENCE

INDIAUS UNITED KINGDOM AFRICA VIETNAM

New York 575 Lexington Avenue,New York, NY 10022

Sierra Leone 9 Jakema Street, Bo, South Sierra Leone

56 Pennington, Orton goldhay, Peterborough Pe2 5rb

Himachal PradeshAashirbad Building, I & II Floor, Kamal Marg, Nehran Pukhar, Dehra - 177104

Hanoi 27 Hang Bai, Hanoi Vietnam

INDIA

HyderabadB, Plot no. 20, Avanthi Enclave, Madinaguda, HyderabadTelangana-500049

INDIA

DelhiH-1/603, DDA Multi-Storey,Sector-18B, Dwarka,New-Delhi-110087

CANADA

Ontario 3388 sandwich street, appt. 213 Windsor, Ontario - N9C1B1 Canada

Global Comprehensive Service Portal -Drugs & Device Development

Clinical Research Units

PK/PD Modelling

Data Visualization & Analysis

Pharmacodynamic Models & Simulations

Real World Intelligence

Real World Evidence Strategy & Analytics

Real World & Late Phase Research

Direct to patient contact solutions

Strategic Regulatory Services

Clinical & Medical Translations

Linguistic Validation

Clinical Research Services

Post Marketing Compliance

MedTech Technology

Compliance Solutions

EarlyDevelopment

ServiceCommercialization

& OutcomesLanguageServices

MedTechDevelopment

Services

FSP Resources for Clinical Development

& Post Marketing Program

FunctionalServices Provider

Global Comprehensive Service Portal -Drugs & Device Development

Biostatistics

Data Management

Medical Writing & Publishing

Adaptive trial

Medical Affairs

Pharmacovigilance

Interactive Response Technology

Clinical Trial Supplies Management

Preclinical/Non-Clinical Development

ClinicalDevelopment

Pharmacokinetics

Due Diligence

BiometricsScientific

Operations

DrugDevelopment

Services

Project Management

Clinical Operations

Feasibility, Start-up & Regulatory

Site & Patient Solutions

Patient Recruitment and Retention

Services

Clinical Research Services

FULL-SERVICE CAPABILITIES & EXPERTISE

Throughout the clinical development life cycle, Fervor provides medical and regulatory leadership guidance and efficient, disciplined operational execution of studies around the world. Our comprehensive capabilities, resources and global footprint ensure quality and timely development across all phases of research.

Early Phase Phase 1 Phase 2 Post Marketing

CLINICAL TRIAL OPERATIONS

Fervor’s Expertise with unmatched proactive, responsive and pragmatic approach tailor-made to match the specific needs of your projects. Fervor’s global experience in effectively designing and executing studies, partner from strategy to approval in complex indications and modalities across a therapeutic areas and patient populations. Fervor offers either singly or as a full-service solution.

Protocol Development

& Study Design

PatientRecruitment

Study Startup& Feasibility

Clinical Project & Program

Management

SiteManagement

& Clinical Monitoring

MedicalServices

Safety& P’covigilance

Clinical TrialOversight

TECHNOLOGY UNIQUENESS

Strategic of R&D

Vendor Selection

Vendor Management

End to End Program/Project Management

Customized Project

Clinical Program Rescue

Single Point of Contact

Expertise in Clinical Development Services

Accountability & transparency with a proven record of successful delivery

Timelines & risks are managed proactively

Applying knowledge from past experiences to ensure accurate financial management

Strategic advice on registration and commercialization

Performing regulatory feasibility for a new program or a new project

Support in planning of a Program with a multiple projects or an individual projects

Identifying, auditing, and supporting in managing the local vendors like Central, Clinical Trial Supply management vendor, Data Management, PVG and so on

Delivering consistency across programs and submissions

Covering all therapeutics areas and indications

Our Clinical Development Services (CDS) Project Managers provide solution-focused project management across our single, multiple and full service and Full-Service CDS business lines, so you have one point of contact for each project within CDS. Our CDS Project Managers provide support for all non-therapeutic Business Unit specific areas, from Early Phase through the support of regulatory submissions

We offer Services Outcomes

REGULATORY & DEVELOPMENT SERVICES

Fervor’s delivers the innovative regulatory strategies for the complex programs or borderline productsor the products where the regulatory pathways are not straight forward for the Pharmaceuticals,Medical Devices, and Biotechnology companies

ClinicalPharmacology

ProductDevelopment

Strategy &Planning

Nonclinical/ safety

strategies

RegulatoryDue-Diligence

GapAnalysis

ClinicalDevelopment

Planning

Critical RiskIdentification

RegulatoryDevelopment

Strategy &Submissions

ContingencyPlanning

FERVOR is committed to providing the highest quality services.

Our global Data Analytics group is a dedicated & experienced team of biostatistics, statistical programming, and data management professionals devoted to delivering individualized,adaptable, and dedicated services to support all your data and analytical needs.

The key to excellent data management is flexibility. We respond to your needs by nimbly adjusting to change and striving to avoid timeline modifications. This ability is the true mark of a valuable CRO partner — but FERVOR surpasses that basic data management function by applying strong cost-effective measures, quality assurances, and therapeutic and regulatory expertise.

BIOMETRICS AND DATA ANALYTICS

Statistical Analyses & SAP

Design CRF as per CDASH Standard

Statistical Consulting & Development Strategy

CDSIC: SDTM & ADaM

Double-Data Entry (Paper CRF)

Operate Seamlessly in multiple EDC platform

Preparation & Generation of Randomization Plan

Interpretation of Study Result and Writing Report

THERAPEUTIC AREAS

Attain faster pathways to commercialization, achieve greater efficiencies through better designed andexecuted clinical research studies, and effectively navigate global regulatory requirements to optimizeyour product’s success. Your project team will be led by medical, regulatory and operational experts with deep therapeutic experience who are fully engaged throughout your study, proving guidance and averting potential roadblocks by staying close to the project.

01 Cell & Gene Therapy

02 Rare & Orphan Disease.

03 Oncolog & Hematology

04 Central Nervous System

05 Hepatology & Gastroenterology

Additional Areas of Focus

Infectious Disease

Endocrinology & Metabolic

Cardiology & Vascular

Dermatology

Respiratory & Pulmonology

Nephrology & Urology

Obs/Gynae/Women Health

Pediatrics

Device & Diagnostics

We treat your drug development journey as if it’s our very own,

providing VALUABLE INSIGHT,

UNMATCHED CLIENT SERVICE, & HIGH-QUALITY

DELIVERABLES.

DRUG SAFETY AND PHARMACOVIGILANCE

Perform a full Medical Review,including protocol deviations

Share clinically relevant trends with sponsors

Continuously assess therapeutic response

Interact with CRAs to identifysafety issues early

Customized Safety Surveillance

Safety Narrative Writing

Safety Signal Management

Aggregate Report Management

AE/SAE Mgmt. & Reconciliation

Individual Case Reporting

Safety Coding (MedDRA, WHO Drug

Blinded/Unblinded Services

Updating of IB with new Safety Information

FERVOR has deep expertise and experience from early phase studies to marketed products. FERVOR is asafe pair of hands to support clients in both current state whilst planning for your strategic objectives. OurPV SMEs, comprised of both Physicians and Scientists are end-to-end partners for our clients, proactivelyadvising and collaborating in designing and maintaining PV services and systems which are fit-for-future.

Medical Affairs Pharmacovigilance

We know how important your product is to you and the patients who are waiting

GLOBAL REGULATORY AFFAIRS

Drive the development of your products – from preclinical proof-of-concept candidatesto approved products primed forpost-marketing label extension andregulatory maintenance – by partnering with an experienced partner who knows how to help you reach your long-term commercialgoals.

Fervor’s highly skilled team of globalregulatory experts are available to provide guidance and support for your products at any stage of clinical development for drugs and medical devices.

Partnering with our clients in all stages of their product development programs and product lifecycleto accelerate global therapeutic development and enable access to the market

FHS

StrategicDevelopment

Preparation&

Submissions

RegulatoryCompliance

AcceleratedPathways

BorderlineProducts

RegulatoryAgency

Interactions

MedicalDevices &

Diagnostics

CombinationProducts

TECHNOLOGY SOLUTIONSLeveraging Fervor’s differentiated technology solutions and

data collaborations

Real world Data

Collaboration

EDCSystems

World ClassAnalytics &

Collaborations

World ClassPVG

Systems

FERVOR SITE NETWORK

Site Selectedto Site

Initiation Visitis on average

35% Faster

Speed

Average of55% more

patients persites

Patients

12 audits &inspections over

4 years – NoMajor/Critical

Findings

Quality

FERVOR works in partnership with the leading medical institutions across Asia to accelerate quality clinical research for its clients and has now signed 16 major strategic partnerships with hospitals and research institutions in the region.

Fervor Site Network is focused on reducing study start-up times, achieving early enrollment targets and high retention rates with an enhanced patient experience

CLINICAL SUPPLIES MANAGEMENT SERVICES

FERVOR Clinical Supplies Management is an integrated biopharmaceutical supply chain solutions provider offering a full range of primary and secondary clinical packaging, temperature-controlled logistics, storage and distribution services for the global pharmaceutical, biotech and Medical Device industries.

IntegratedClinical

Supply Chain

Door to DoorDelivery

Warehouse &Transportation

Biological Sample

Shipping Services

Integrated Project

Management

CustomsClearance

PersonalizedLogistics Services

RegulatorySupport

www.fervorhs.com

hello@fervorhs.com

+91 8527110300 +91 88600 09879 + 91 78740 33093

Headquarters: H-1/603, DDA Multi-story, Dwarka, New-Delhi-110078, India

CONTACT US