FERVOR PPT v2
Transcript of FERVOR PPT v2
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CORPORATE PROFILE
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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.
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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
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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
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TECHNOLOGY SOLUTIONSLeveraging Fervor’s differentiated technology solutions and
data collaborations
Real world Data
Collaboration
EDCSystems
World ClassAnalytics &
Collaborations
World ClassPVG
Systems
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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
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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
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www.fervorhs.com
+91 8527110300 +91 88600 09879 + 91 78740 33093
Headquarters: H-1/603, DDA Multi-story, Dwarka, New-Delhi-110078, India
CONTACT US