CloudOffshore

OffsiteOnsiteInformation Technology
Serviceswww.dmpdeccan.co.jp

DMP & DECCAN offers flexible IT Subcontracting, IT
Consulting, ITaaS Managed Services, and IT system/process
outsourcing solutions & services based on our onsiteoffsite-offshore Hybrid IT business model for the Life
Sciences industry IT organizations in Japan.

IT Subcontracting

IT Subcontracting (Ukeoi Contracts):
DMP & DECCAN identifies and works with the JapaneseEnglish bilingual, domain experienced, technicallyqualified/certified inhouse-freelance-independent IT
professionals (subcontractors). We are perfectly positioned tosupport IT Subcontract projects of any size on short-mediumlong term engagements in Japan. Such projects include ITConsulting, ERP applications development, and Infra
maintenance/support which can be outsourced/contracted toDMP & DECCAN for an agreed upon fixed fee to be paid on amilestone or contingent fee basis.

Permanent IT Hiring:

IT Recruiting

IT Consulting/ITaaS

DMP & DECCAN holds the Japan MHLW issued recruitment
license (Recruitment #: 13-ユ-310289) to undertake
permanent recruiting in Japan. Our Executive SearchSpecialist Recruitment practice focuses on recruiting full time
IT Professionals (FTEs) into the permanent roles in the LifeSciences industry. Our IT search engagements are dedicatedto the Subject/System Matter Experts (SMEs), engaged in
Clinical, Regulatory, Medical, and PV & Safety functions. Our
IT Recruitment Process Outsourcing (RPO) is when our Clientcompany transfers all or part of its permanent recruitment toour company (an external provider).

IT Subcontracting (Ukeoi) Engagement Model
Customer(Consigner)

Customer: Customer (Consigner) entrusts DMP & DECCAN(Contractor/Consignee) to complete IT projects based on SLAs andSOWs and the fixed fees to be paid thereof for the services.
Contractors are hired to complete IT project as it is laid out in acontract (Master Agreement for Client – Contractor framework).

Contractor: Contractors are hired by Clients to perform the workin the contract on a time and materials basis only, then move on to
the next project and/or contract. There are no lasting ties to theemployer (Customer) and no obligations, such as social insurance
or taxes.

Contractor(Consignee)

Subcontractor: A subcontractor (or Independent Contractor) isSubcontractor(Consultant)

hired by the Contractor or project owner to complete a certain task
entrusted by the Customer and the fixed fees to be paid by theContractor thereof for the services. Subcontractors also work undera separate contract on a time and materials basis only
(independent contract) with Contractor (further specified in theStatement of Work – SOW). They are not employees or a part ofthe Customer or Contractor that hired them for specific tasks.
There are no lasting ties to the employer (Contractor) and noobligations, such as social insurance or taxes. When the assignedtask is finished, the subcontractor is off to the next project.

IT Consulting (ITaaS) Services Engagement Model
Consulting Services(Dev/Infra)

Managed IT Services(ITaaS)DMP & DECCAN IT Services Engagement Model canprovide flexible IT Project Management to Clients inJapan due to our forged partnership with nichedomain specific IT Services & Solutions companies
from our offshore delivery centers in India. Clients inJapan need not hire FTEs for demanding ITDevelopment or Infra Maintenance & Support projects
that need Subject/System Matter Experts only for aspecific period or a project.

Japan Onsite Support ServiceCloud ComputingServices

Japan Offsite Support Service
India Offshore Support ServiceSignificant IT Roles & Functions We Support

Digital Transformation

Software/App Development

IT Infrastructure

Cyber Security

Data Management

IT provides diverse and growing opportunity for service providers
like DMP & DECCAN. Some are "High Demand" and some areimportant to the "Future of Life Sciences IT". With this knowledge,
we strive to support following significant IT Roles/Functions inJapan.

Data Management/ Analytics▪ BI Architect/Analyst/Developer▪ Data Engineer▪ Data Scientist▪ Database Architect
Cyber Security▪ Cyber/Information Security Engineer/Analyst▪ Security Management SpecialistIT Infrastructure▪ Network Engineer/Architect▪ Network/Systems Administrator▪ Systems Analyst▪ Computer Support Specialist
Software/App Development▪ Blockchain, Machine Learning (ML), Artificial Intelligence (AI)Designer/Developer/Engineer▪ Mobile App Developer▪ SW Developer/Engineer▪ UI/UX Designer/Developer▪ Web Developer
Digital Transformation▪ Change Management▪ IoT Designer/Engineer▪ Transformation Consultant

IT Candidates and Consultants Talent Pool
DMP & DECCAN works with a large pool of IT Talents – Freelancers andIndependent Consultants to manage your IT Subcontract Projects or qualified
candidates to recruit for Full-time IT roles. Our Candidates and Consultants,
apart from native Japanese, come from different countries. They all haveJapan work permit, are proficient in English-Japanese, and hold relevant
language and professional Certifications.

LanguageProficiency

Language Proficiency
Native Japanese (English Language Proficiency)
Native or Bilingual – 30%
Full Professional – 50%
Limited Working – 20%
Non-Native Japanese (Japanese Language Proficiency)
Native or Bilingual – 30%
Full Professional – 50%
Limited Working – 20%

Non-Native Japanese Nationality Profile
Asia (India, China, Vietnam, South Korea, etc.) – 50%
US-EU (USA, Canada, UK, Germany, France, etc.) – 35%RoW (Rest of the World) – 15%

Licenses & Certifications

Licenses &Certifications
Multinational
Talents

JLPT Level (N3 to N1) | TOEIC Score (750 to 950)
Project Management Professional (PMP)
ITIL Foundation
AWS (Amazon Web Services) Certified
VMware Certified
Citrix Certified
Microsoft Certified
Cisco Certified
Six Sigma
Certified Scrum Master (CSM)
Certified Ethical Hacker (CEH)
Certified CGEIT/CRISC/CISA/CISSP/CISM, etc.

Pharmacovigilance/Drug Safety System Support Services
Global Safety Database Implementation

Global Safety
Database
Implementation

Global Safety
DataMigration

Cloud
ComputingServicesDMP & DECCAN provides IT services & solutions to help Life
Sciences companies in Japan to manage and maintain their drug
safety and other critical applications/tools. We support GlobalSafety Database Implementation, Global Safety Data Migration,and Safety Cloud Computing services using our flexible OnsiteOffsite-Offshore hybrid business model.

▪ Validation▪ Data Migration▪ Project Management▪ Production Support▪ On-premise to Cloud▪ End User Training

Global Safety Data Migration▪ ARISg/ARISj (LSMV10)▪ Argus/ArgusJ▪ ClintracePerceive Ace/PV▪ AERS/Emperica Trace/RxLogix▪ Home grown system, Excel, XML▪ Single Tenant/Multi Tenant Migrations

Cloud Computing Services▪ On-premise to Cloud▪ Microsoft Azure Platform▪ Amazon Web Services (AWS)▪ Salesforce.com▪ IBM/Gogol/SAP/Oracle▪ VMware/ServiceNow/WorkdayERP & CRM IT Support Services for the Life Sciences Clients in Japan
DMP & DECCAN provides IT services/solutions to help Life Sciences companies
in Japan to manage and maintain their Customer Relationship Management(CRM) and Enterprise Resource Planning (ERP) systems/applications/tools. We
work with a large pool of IT talents – freelancers/independent consultants tomanage your IT subcontracting/business outsourcing projects or recruiting fulltime employees (FTEs) into the permanent roles in the ERP & CRM space.

Freelancer/ExperiencedConsultants
Global ERP/CRM
Support
ERP/CRMServices

Freelancer/Experienced Consultants▪ Development and Customization▪ Technical and Solution Architecture▪ Process Business Consulting▪ Configuration, Admin and Testing▪ Project/Program Management▪ On-premise to Cloud Transition
Global ERP/CRM Support▪ SAP ERP
▪ NetSuite▪ Oracle ERP▪ Microsoft Dynamics▪ Salesforce HealthCloud▪ Veeva CRM Suite▪ Data+/Aurea CRM/CRMNEXT, etc.

ERP/CRM Services▪ Contingent Project Management▪ ERP/CRM Technical Advisory▪ Permanent Hiring/Recruitment▪ ERP/CRM RPO Services

Custom Technology Solutions and Software Services via India Offshore
Application Development Services
Business Partners
We rely on our technological expertise and specialized industry
Our offshore business partners' background comes from industry
experience as well as life science consulting, safety database
implementation, maintenance, cloud solution analytical services.
The team is experienced with various regulatory agencies(including PMDA Japan) which place us in the unique position tosupport our clients in Japan with an end-to-end solution to Safety
Database management.

Application Development
Application Maintenance
IT Security
Infrastructure Support
Software Migration

experience to develop any type of web, mobile, desktop, and hybrid
app per your business requirements.

Application Maintenance Services
Our application maintenance efficient modernized services aredesigned to ensure the scalability, performance, and sustainability ofyour entire software infrastructure as your business grows.

IT Security Services
Our business conscious threat audits help us identify yourinfrastructure's most pressing vulnerabilities, allowing us to integrate
the encryptions, security services as per business need.

Infrastructure Support Services
We address client’s key business assets from multiple perspectives,that requires to allow an organization to become an effective digitalenterprise with the help of our end-to-end infrastructure services.

Software Migration Services
We perform cloud-based migrations, system upgrades and other vital
software modernization services with utmost focus and prioritizing
system uptime and data integrity.

RPO

Retainer

Contingency

Executive Search-Recruitment
and RPO Services

www.dmpdeccan.co.jp

DMP & DECCAN Executive Search-Specialist Recruitment practicefocuses on recruiting full time employees (FTEs) into thepermanent roles in the Life Sciences industry in Japan. Our searchengagements are dedicated to the following two Functional
Categories:

Life Sciences Core
FunctionsLife Sciences Back Office
Functions

We support a range of Life Sciences industry
clients such as Pharma Sponsors, Clinical
Manufacturing Organizations (CMOs), ClinicalResearch Organizations (CROs), and domain
specific technology MNCs, specializing in bothBusiness operations/Back Office and Digital cloudspace (Life Sciences ICT) across departmental
functions.

Life Sciences Core Functional Specializations:
Key Opinion Leaders (KOLs), Subject/System Matter
Experts (SMEs), and Health Care Professionals (HCPs)
engaged in Clinical, Regulatory, Medical, and PV &Safety functions.

Life Sciences Back Office Functional
Specializations:
Supply Chain & Procurement Specialists (SCM), Human
Resources & General Affairs Specialists (HR & GA),
Finance, Accounting, and Audit Specialists (F&A/Audit),and Environmental/Occupational Health & Safety
Specialists (EHS).

At DMP & DECCAN, we offer three different
Recruitment Engagement Models (fee structures)
depending on the Client’s requirements:

Recruitment Engagement Model
Success BasedEngagement

Retainer BasedEngagement

RPO Based
Engagement

Success Based (Contingent Search) – by which we
charge a percentage fee contingent upon the candidate
is hired.

Retainer Based (Confidential Search) – by which
we charge an agreed upon fee in three stages: at thestart, upon acceptance of the short list and at the end ofthe search.

RPO Based (Managed Search) – Recruitment
Process Outsourcing (RPO) is when our Client company
transfers all or part of its permanent recruitment to ourcompany (an external provider).
We focus on building a rich pipeline of niche domain
expertise to support our clientele by leveraging the Life
Sciences industry Business-Alliance-Partnership「MEDiTalent™」 engagement experience through anetwork of Key Opinion Leaders (KOLs), Subject/System
Matter Experts (SMEs), and Health Care Professionals(HCPs) engaged in Clinical, Regulatory, Medical, and PV &Drug Safety system and process operations functions.

Life Sciences Core Functional
Specialization

Subject Matter Expertise▪ Key Opinion Leaders (KOLs)▪ Subject/System Matter Experts (SMEs)▪ Healthcare Professionals (HCPs)

Domain Specialization
Subject MatterExpertise

FunctionalSpecialization▪ (Bio) Pharmaceuticals▪ Medical Devices/Technology▪ Cosmetics/Neutraceuticls

Functional Specialization▪ Pharmacovigilance/Drug Safety▪ Japan GxP Compliance (RA)▪ CRO Clinical Affairs

DomainSpecialization

Life Sciences Core Functional SearchEngagements▪ Enterprise-Solution-Infrastructure-Cloud IT Specialists▪ Pharmacovigilance/Drug Safety Specialists▪ Quality, Safety and Compliance Specialists▪ Clinical Development Specialists▪ Regulatory Affairs Specialists▪ Medical Affairs Specialists

Life Sciences Back Office Functional
Specialization
Supply Chain &Procurement
Human Resources& General Affairs

Supply Chain & Procurement▪ Supply Chain Director/Manager▪ Logistics Planning▪ Demand Forecasting/Supply Planning▪ Import Operations/Inventory Control▪ Warehouse Management/Distribution▪ Order Management▪ Purchasing/Sourcing▪ Indirect Procurement

Human Resources & General Affairs▪ HR/GA Director▪ HR Business Partner (HRBP)▪ Talent Acquisition Specialist▪ Compensation & Benefits Specialist▪ Learning & Development Specialist▪ Organizational Develoment (OD)
▪ Leadership Training/Coach▪ HRIS and HR Operations

F&A,Legal, EHS Compliance

F&A,Legal, EHSCompliance▪ Finance Director/Controller/CFO▪ FP&A Specialist/Analyst▪ Tax Accounting/Audit Specialist▪ Legal Compliance Specialist/Counsel▪ Regulatory Compliance▪ EHS Specialist (Manufacturing/Facilities)▪ Occupational Health & Safety▪ Field/Process Safety Specialist

Recruitment Process Outsourcing (RPO)
Recruitment Process
Outsourcing (RPO) is when ourRPO Client

RPO Provider

Client company transfers all or part ofits permanent recruitment to an
external provider such as DMP &DECCAN. We can act as an extensionof our Client company's HR or
Resourcing/Talent Acquisition
function, sitting on site with theclient providing a holistic hiringsolution.

Business
Advisory
GxP
Compliance
Advisory

AE CaseManagement

Project Consulting and Process
Outsourcing Services

www.dmpdeccan.co.jp

Life Sciences Project Consulting
Services
Business Matching Services

Regulatory ConsultingServices
Pharmacovigilance/Drug
Safety Services

Japan PV/Drug Safety Consulting
Services
DMP & DECCAN offers business expertise andindustry knowledge through A Step-by-Step
project consulting support to kick-start yourPharmacovigilance/Drug Safety StrategicBusiness Unit (SBU) in Japan in the following
areas of expertise:▪ Japan Pharmacovigilance Market Snapshot (Executive Report)▪ Go-To-Market (GTM) strategy advisory▪ Pre-Sales support▪ Request for Proposal (RFP) writing in English and Japanese▪ PV Capabilities Presentation Deck creation in English and Japanese▪ Japan PMDA Regulatory specific E2B (R3) and Green Book (J-Items)
AE Reporting Requirements guideline in English▪ Bilingual (E-J) Concise Japanese PV Glossary (excel) for
onshore/offshore AE Case Management team
▪ Service Supplier (PV Outsourcing Vendor) Qualification Audit
checklist orientation▪ J-GVP Quality Self-Inspection Implementation and CAPA
management regulatory guideline training▪ QC check of AE Case Management project related SOPs, PMP, BCP,SOW, SLAs.

Pharmacovigilance AE CaseManagement Services

Comprehensive AE CaseManagement

AE Case Management Engagement Overview
Transition | Training | Go-live | Retrospective Review | Post Go-live

Comprehensive
AE CaseManagementCase
Processing
Workflow

Local/GlobalSafety
Database

DMP & DECCAN has the capability to provide the necessary resources forComprehensive AE Case Management of all serious and non-serious adverse
event cases as requested by Sponsors, including but not limited to:spontaneous post-marketing cases, clinical trial cases, cases forwarded by theregulatory agencies, literature cases, and legal cases. DMP & DECCAN uses
stringent metrics for the case processing team, which will be reviewed during
the transition period.

▪ Spontaneous Post-marketing Cases▪ Clinical trial cases▪ Regulatory Agency forwarded cases▪ Literature cases▪ Legal/Offlabel cases

Case Processing Workflow▪ Case Intake/Triage▪ Data Entry (DE) / Coding (MedDRAj)▪ Quality Review/Check (QC)
▪ Case Assessment/Translation▪ Case Report Preparation

Local/Global Safety Database▪ ARGUSg/J▪ ARISg/J▪ Percieve Ace/PV▪ AERS/Empirica/Clintrace/RxLogix▪ Homegrown Systems/Excel/XML, etc.

Japan Regulatory Submission Support
DMP & DECCAN will act as a Single Point of Contact (SPOC) for
providing local Regulatory Consulting support from time to timethrough our Partner Consultants (SMEs), local Regulatory Affairs
Consulting firms and CRO partners, in areas of Drugs, MedicalDevices, Cosmetics, Food & Dietary Supplements, Biotech, OTC
and their registrations/submissions.

Japan Regulatory Submission
SupportJapan Business MatchingServices

Japan Regulatory Submission Support
Our support includes but not limited to following:▪ Pre-Sales support▪ RFI/RFP documentation support▪ Assisting Client teams for the Proposals/ Quotes of theservice requested by end customers (service buyers)▪ Identifying License Holding/ Legal Representative –▪ In-Country Clinical Caretaker (ICCC) and DesignatedMarketing Authorization Holder (DMAH) facilitation▪ Identifying Distribution partners

Japan Business Matching Services
Using our Business-Alliance-Partnership engagement model,
DMP & DECCAN will act as a Single Point of Contact (SPOC) for
facilitating Business Matching Support for both Japanese andforeign Biotech companies seeking desired business partners
for expansion in the following areas of activities:▪ Joint Venture and M&A Partnership▪ In-Licensing and Out-Licensing▪ Joint Research and Development▪ Manufacturing Service▪ Sales of Reagents▪ Product Licensing▪ Technology Licensing▪ Distributorship Agreement, Agency Agreement▪ Testing Services

Contact Us | 080-9085-6658
DMP & DECCAN GROUP K.K.
Yamate Bldg. 4F, 4-6-5
Higashi-Nakano, Nakano-ku,
Tokyo 164-0003 Japan
Tel.: 080-9085-6658
E-mail: contact@dmpdeccan.co.jp