ICON Clinical Research GK

Booth No.：5M-06

Category：Outsourcing

Company Information

Email： Japan_Communications@iconplc.com TEL： Address： 541-0056
Osaka Center Bldg. 4-1-3 Kyutaro-machi, Chuo-ku, Osaka-city, Osaka JAPAN URL： https://www.iconplc.com/

ICON is a global CRO providing comprehensive services aimed at improving the efficiency and success rates of drug, medical device, and regenerative medicine product development.
We offer consulting, clinical trial implementation, project management, support by Japanese representatives, regulatory submission assistance, and post-approval services to meet your clinical development needs, not only in Japan but also for approvals in Europe, the United States, and Asia. Please feel free to contact us.

Company information

Address	541-0056 Osaka Center Bldg. 4-1-3 Kyutaro-machi, Chuo-ku, Osaka-city, Osaka JAPAN
URL	https://www.iconplc.com/
Email	Japan_Communications@iconplc.com

Product introduction	Clinical Research Outsourcing Services (Full Service/FSP) Pharmacovigilance Medical Writing (CTD, Protocol, IB, CSR) Biometrics (Data Management, Biostatistics, SAS Programming) Various Laboratory Services Medical Imaging Cardiac Safety DCT（Decentralized Clinical Trial） FDA Pre-IND Meeting/Gap Analysis/Review of FDA Meeting Package IND Preparation and Submission/USA Agent Services NDA/BLA Submission Support US Medical Device 510(k) Submission Japanese Liaison Services PMDA Consultation Support(Pre-meeting, formal meeting) Orphan Drug Designation (ODD) Application Support Regulatory CMC Services Clinical Development Plan Development(Target Product Profile, KOL Outreach) Business Plan Development(Payer Research, Health Technology Assessment (HTA) , Sales projection) Bioanalytical Laboratories Clinical Research Units(FIH Studies (Healthy Volunteer, Patient), PK/PD Modeling & Simulation, Clinical Pharmacodynamics, Clinical Pharmacology, NONMEM & PDx-Pop Software)

Product introduction

Clinical Research Outsourcing Services (Full Service/FSP)
Pharmacovigilance
Medical Writing (CTD, Protocol, IB, CSR)
Biometrics (Data Management, Biostatistics, SAS Programming)
Various Laboratory Services
Medical Imaging
Cardiac Safety
DCT（Decentralized Clinical Trial）
FDA Pre-IND Meeting/Gap Analysis/Review of FDA Meeting Package
IND Preparation and Submission/USA Agent Services
NDA/BLA Submission Support
US Medical Device 510(k) Submission
Japanese Liaison Services
PMDA Consultation Support(Pre-meeting, formal meeting)
Orphan Drug Designation (ODD) Application Support
Regulatory CMC Services
Clinical Development Plan Development(Target Product Profile, KOL Outreach)
Business Plan Development(Payer Research, Health Technology Assessment (HTA) , Sales projection)
Bioanalytical Laboratories
Clinical Research Units(FIH Studies (Healthy Volunteer, Patient), PK/PD Modeling & Simulation, Clinical Pharmacodynamics, Clinical Pharmacology, NONMEM & PDx-Pop Software)

Product introduction

Clinical Research Outsourcing Services (Full Service/FSP)PharmacovigilanceMedical Writing (CTD, Protocol, IB, CSR)Biometrics (Data Management, Biostatistics, SAS Programming)Various Laboratory ServicesMedical ImagingCardiac SafetyDCT（Decentralized Clinical Trial）FDA Pre-IND Meeting/Gap Analysis/Review of FDA Meeting PackageIND Preparation and Submission/USA Agent ServicesNDA/BLA Submission SupportUS Medical Device 510(k) SubmissionJapanese Liaison ServicesPMDA Consultation Support(Pre-meeting, formal meeting)Orphan Drug Designation (ODD) Application SupportRegulatory CMC ServicesClinical Development Plan Development(Target Product Profile, KOL Outreach)Business Plan Development(Payer Research, Health Technology Assessment (HTA) , Sales projection)Bioanalytical LaboratoriesClinical Research Units(FIH Studies (Healthy Volunteer, Patient), PK/PD Modeling & Simulation, Clinical Pharmacodynamics, Clinical Pharmacology, NONMEM & PDx-Pop Software)