● Company Information ● Our Services ● Experience ● Our Network

Grown up locally, stretched out globally

Your strategic partnerGrown up locallyStretched out globally

DreamCIS (dri:m si: ai es)

03 08Company Information Our Services

15 18 Experience Our Network

Contents

Company Information

About DreamCIS ●

Our Mission and Vision ●

Company History ●

Organizational Chart ●

About DreamCIS

04Company Information 05Company Information

Our Mission & Vision

Mission“To contribute to build healthier and happier communities together with

pharmaceuticals and investigators.”

Vision “To be a representative clinical research organization in Asia which leads

global standards by 2019”

DreamCIS is a contract research organization (CRO) providing clinical research services to the pharmaceutical, biotechnology,

medical device, and functional food industries.

Through the scientific and systematic quality management, DreamCIS is dedicated to satisfy our clients’ needs based on strict

ethical consciousness.

To achieve this, DreamCIS follows the guidelines of all clinical research services, such as KGCP, ICH, and DreamCIS’ standard

operating procedures (SOPs). Moreover, we provide the reliability on developing products through the systematic

management in clinical research and continuous improvements on quality.

Since its establishment in April 2000, DreamCIS has supported the local major

pharmaceuticals, global pharmaceuticals, biotechnologies, functional foods and

medical devices industries and gained its trust. Furthermore , we have generated

the synergy effect by making MOU with Regional Clinical Trial Centers (RCTC) and

actively involving in clinical trials with them.

All employees at DreamCIS as a business partner to our clients promise that we

will provide the best clinical research services.

Vision Mission

06Company Information

CEO

Management

Medical Writing

Medical ConsultingR&D

PM Group(2 Teams)

CRA Group(4 Teams)

SSU

Clinical Research

PM Group(3 Teams)

IRB Affairs

CRA Group(2 Teams)

Quality Control

Late Phase Study

Data Managment

Statistical AnalysisBiometrics

EDC Team(2 Teams)

System Team

Solution Team

Information Technology

07Company Information

Organizational Chart

2000 04 DreamCIS was founded

2004 04 Started collaborating with global pharmaceuticals

200703 Managed the “R&D University” with Pfizer from 2007 and on 04 Systematized the program for internal training

2008 09 Established Biometrics Center

2009 07 Introduced Oracle Clinical System (First introduction in Korea)

2011 01 Established Busan office

2012 10 Launched DreamTrial (eCRF)

2013 12 Achieved 20 billion annual sales (in KRW) for the first time among foreign/domestic CROs in Korea

201502 Started collaborating with Medidata07 Established Japan office

Business Development

Japan Office

Quality System

Busan Office

Company History

Our Services

Clinical Trials ●

Late Phase Study ●

Data Management ●

EDC System ●

Biostatistics ●

Clinical Trials

09Our Services

DreamCIS CRBU provides a full scope clinical trials service from phase 1~4,

including IIT and well-trained and experienced CRAs make sure to deliver

quality data on time, and overall project is efficiently managed by veteran CR

managers.

Service Scope● Consulting● Study design● Project Strategic Planning● Protocol & CRF Development ● Project Management ● Regulatory Affairs(MFDS, IRB)

● Feasibility Study ● Initiation Visit● Regular Monitoring Visit● Close Out Visit● CSR Writing● SAE Affairs

10

DreamCIS conducts Late Phase Study service encompassing all types of

post-marketing surveillance(PMS), either for the entire project or certain stag-

es of project, that include PMS, periodic reports and re-examination reports,

Pharmacovigilance, and marketing promotion.

Late Phase Study

Our Services

● Consulting

● Study Design

● Protocol & CRF development

● Feasibility check● Project Management

● Regulatory and IRB Affairs

● Site Contract

● Monitoring(Initiation Visit, Regular Monitoring Visit, Close-out Visit)

● Site Management

● CSR Writing

● Re-examination & Periodic Report Writing(PMS)

● SAE Affairs

Service Scope

DreamCIS Data Management Center is constantly working to create the real

value of clinical trial data through reliable data management by establishing

the SOPs in compliance with the ICH Guideline, 21 CFR Part 11 and KGCP for

processing of valuable clinical trial data for clients.

11Our Services

● Data Management plan

● Database Designing

● Data Entry

● Data Validation & Verification

● Medical Coding

● SAE Reconciliation

● Data Fix

● Electronic Data Transferring

Service Scope

Data Management

DreamCIS provides reliable EDC system with DreamTrial and Medidata Rave.

Data Management Team with professionals including experienced IT Administrator,

Software Engineer, Software Project Manager, and System Architect to build a suc-

cessful EDC system. We provide a full range of services from system development

to maintenance and operation, based on state-of-the art technology in compliance

with international quality standards.

EDC System

12Our Services

● GS (Good Software) Certified by TTA

(* TTA: Telecommunications Technology Association)

● Web Security inspected

● Customized and specialized for Korean language

● Collaboration with Medidata started from

early 2015

● DreamCIS professionals who completed Medidata

Training Program manage and operate Rave

Architecture Management ● Infrastructure Management

● System Performance Check

● Backup Management

● Network Traffic Management

System Development● EDC Development

● Online E-Learning Service

● SAE report customization & service

● Addional Fuction Development

13Our Services

Request Management● Technical review and implementation of request item.

● Issue resolution process.

● Description of a development method and issue resolution

Quality Control● Define user requirement

● System Test & Source Code Review

● System Verification

EDCOffice

System Development

Architecture Management

Quality ControlRequest

Management

14Our Services

ExperienceClinical Trials ●

rPMS&NIS ●

Therapeutic Area ●

BS Team provides optimal study designs which seek to attain study objective

and reach the scientific conclusion.

The highly qualified and trained biostatisticans have abundant experience in

various statistical analyses.

Biostatistics

Study Design

● Study Design

● Protocol/CRF review

● Sample size calculation with PASS

● Statistical analysis plan

● Randomization

Statistical analysis

● Statistical analysis modeling

● Statistical programming with SAS

● Result figuring & tabling

● Result interpretation

● Statistical analysis reporting

Service Scope

16Experience

Clinical Trials / rPMS & NIS(Non-Interventional Study)

For recent 5 years (Jan 1st 2010 ~ Sep 30th 2015)

Clinical Trials Total : 305

PhaseⅡ 43

PhaseⅠ 44

PhaseⅢ 101

PhaseⅣ 68

IIT 49

rPMS & NIS Total : 316

r-PMS NIS

205

111

17Experience

Updated as of Sep. 2015

Therapeutic Area

01 Cardiovascular

02 Dermatology

03 Endocrinology

04 ENT

05 Gastroenterology

06 Hematology

07 Hepatology

08 Immunology

09 Infection

10 Nephrology

11 Neurology

12 Obstertics/Gynecology

13 Oncology

14 Ophthalmology

15 Infection

16 Psychiatry

17 Respiratory

18 Rheumatology

19 Urology

20 Vaccine

21 Others

Therapeutic Area

01

07

101112

13

141516

17

1819

21

Our Network

19Our Network

Japan

Taiwan

India

Malaysia & Singapore, South-East Asia

USA

Canada

Australia

Europe

China

Hong Kong

Our Network

·Head office - 10F 130, Sajik-ro, Jongno-gu, Seoul, 03170, Korea

TEL. +82-2-2010-4500 FAX. +82-2-720-5385

·Japan office - WIND EBISU Bldg., 4F 2-4-8 Ebisunishi, Shibuya-ku, Tokyo, 150-0021, Japan

TEL. +81-3-6452-5983 FAX. +81-3-6452-5984

www.dreamcis.com