CLINICAL SERVICESSTUDY SET-UP

AKT Health is a Healthcare & Life Science Strategy Consulting ﬁrm. We partner with life science
companies and health systems to develop a market-leading strategy for long-term top performance,engagement, growth, and sustainability.
Our consultants evaluate data, apply analytical models, study systems, and dissect workﬂows to unlock
opportunities to improve performance through technology enablement and engagement planning.

AKT Health is also the sole distributor and promoter of Certara's industry-standard software in India andJapan.

EDC

Study Design

MonitoringPlanCONSULTING SERVICES
IP ServiceStudy
StartupRegulatory
Submissions

Investigator
Training

DataManagement

Laboratory
Preparation

Database Closureand Study
Conclusion

StatisticalAnalysis andReport
Final Report(CSR)

Monitoring
Reporting

Preparation forStarting Study
Site

SafetyManagement

Documentation

Quality
Control

Site andInvestigator
Payment

Preparation of
Study Center for
Inspection andAudit

Results
Presentation
andVisualization
Publication

Patient Travel
Cost and
Reimbursement

REGULATORY SERVICES

In-Country care taker

Pre-Clinical

Feasability Study - Site Selection- Protocol Development

AE Reporting andPatient Registration

CDISC
Conversion

Data ManagementPaper/EDC

Statistical Analysis

Re-Examination

Data Management
Paper/EDC

Periodic Safety Reporting(PSURs)

Post Approval

CTD Preparation
Correspondence With Regulatory Authority
Marketing Authorization Holder (MAH)
Price (NHI) Consulting
GxP Compliance Inspection

CTN Support

Document Preparation
Correspondence With Regulatory Authority

PMDA Consultation
Document Preparation
Correspondence WithRegulatory Authority

Cartagena Application

Clinical Study Report

Approval

J-NDA Support

Development Plan
Data Gap Analysis

Product Launch

Monitoring

Clinical

Regulatory Consulting

Regulatory Aﬀairs
CTM/IMD - Regulatory Authority Consultation

Statistical Analysis

Submission
Package :Documents,Forms andTranslations

Post Marketing
Surveillance and ClinicalSupport - Phase IV

NDA

Clinical Trials

ProjectManagement

EDC App isConnected withmHealth Devices

BudgetClinical Development
Phase I to III

CRA Training

Site andInvestigator
Agreements

Interactive
Website Response
System (IWRS)

Project Plan

Recruitment

eCRF
Programming

Online Reports
Programming

Data
Management
Plan

SupportProtocol
Evaluation

Forms Validation

Feasibility

Regulatory

PortalDevelopment

Study Protocol
Statistical
Analysis Plan

STUDY CLOSURE

Document Preparation
Correspondence WithRegulatory Authority

Clinical TrialMonitoring
Quality Assurance
CSR Creation
Data Management
Statistical Analysis
Pharmacovigilance
Project Management
Investigational
Product Management

Clinical Site Support (SMO)
Patient Recruitment

CTD/Regulatory Dossier

Post-Marketing Surveillance
Pharmacovigilance
Medical Aﬀairs, Sales and Marketing (CSO)
Clinical Site Support (SMO)
Call Center
Patient Communication and Support

GCP Audits

Registration Follow-up

Pharmacovigilance

Non-Clinical Safety Test
Toxicity/Eﬃcacy Evaluation Study
Toxicity/Tumorigenicity Test Using Immunodeﬁcient Mouse
Cell Proliferation Analysis
Soft Agar Colony Formation Test

Quality Assurance Test (GMP)
Sterility
Endotoxin Test

Mycoplasma Test
Residual Test for Antibiotics

In-Process Control Test
Release Testing

Market Authorization

Applied Knowledge & Technology in Healthcare – a philosophy on which AKT Health stands is reﬂectedin our Clinical, Medical, Commercial and Technology services. Each is focused to address the needs ofPharmaceutical, Medical Device and Biotechnology ﬁrms.

DesignSTUDY EXECUTION

UNITED STATES

INDIA

19266 Coastal Highway
Rehoboth Beach, DE 19971

Vipra Elite, Patrikanagar,
Street No: 1, Madhapur,HyderabadJAPAN
1-16-8, Higashi, Shibuya-ku,
Tokyo 150-0011

Medical | Clinical | Commercial | Technology

AKT HealthEstablished2017

45 Employees

Operations in9 Countries andmore than
24 Projects Delivered

9+Expansion

45

Functional Expertsand Developers

REGULATORY AND CLINICAL SERVICES•••IndiaJapanUSA4Offices

Applied Knowledge andTechnology in Healthcare