Our Business Unit

Clinical Project Management , Trial Master File , Clinical Research Monitoring  , Regulatory Management ,Bioequivalence / Biosmiliars Studies , In Vitro Diagnosis Studies , Liver Disease Clinical Research , PK/PD Interaction & Modeling , Data Management

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Operating In More Than 25 Countries, Clinserv Was Able To Run More Than 360 Project For Different Clients Treating More Than 6,500 Patient From More Than 8 Therapeutic Areas. Clinserv Regional Network Includes More Than 500 Key Opinion Leader And 3,000 Healthcare Professional

Study Start Up
Pre-Feasibility And Feasibility Studies
Informed Consent Template - Adaptation Per Country Or Per Site
Management & Review Of Translated Documents
Investigators Meeting -Attendance-Preparation

Regulatory Services:
Central Ec/Irb Preparation , Submission & Approval
Central Ec/Irb Amendments (For Preparation And Submission)
Local Ec/Irb Preparation , Submission & Approval
Local Ec/Irb Amendments (For Preparation And Submission)
Competent Regulatory Authority (Ca) Preparation/Notification (For Observational Study)
Competent Regulatory Authority Submission (For Interventional Study)
Competent Regulatory Authority Amendments (For Preparation And Submission)
Adapt Amended Informed Consent Form To Country Requirements Or Amended Country Icf To Site Requirements

Investigational Product Management:
Import License
Custom Clearance
Collect Documents To Initiate Ip Release To Sites
Review And Manage Site Ip Inventory
Clinical Supply Management

Site Contracts And Administration Of Payments:
Site Contracting (Clinical Trial Agreements)
Investigator Grant Management

Trial Master File:
Preparation Of Investigator
Site File (Isf)Investigator Study File Maintenance Post Mv

Site Initiation Visit:
Site Initiation Visit (Siv) (Onsite)Site
Initiation Visit (Siv) (Remote)

Site Management & Administration:
Site Management (Per Site, Per Month)
Internal Project Team Mtgs With Client : Cra - Communication With Sponsor
Project Administration

Project Management:
Project Administration Project Management During Start Up & Enrollment
Project Management Follow Up Till Closeout
Project Management -Telecom During Setup And Enrollment
Project Management -Telecom During Follow Up Till Closeout

Monitoring Visits
Monitoring Visits (Onsite)
Monitoring Visits (Remote)

Safety Management
Ae/Sae Management
Susars Submission To Ec/Irbsusars
Submission To Ca/Ra/Moh (Competent Authority/ Regulatory Authority)
Report Of Annual Report /Progress Report To Irb/Ecs Or To Ca/Ra/Moh

Close Out:
Close Out Visit (Onsite)-(Remote)
Tmf Reconciliation
End Of Study Submission To Ec/Irb Or Of Study Submission To Ca/Ra/Moh

Staffing Cra,Cta& Pm