csc
csc

Project Management

The role of the Project Manager is
critical to the success of every
clinical trial

Project Management

Clinical Monitoring

Our Clinical Research Associates (CRAs)
are highly qualified and
industry recognized

Clinical Monitoring

Regulatory Affairs

CSC Ltd. takes pride in submitting
excellent IRB submissions.
Our careful attention to detail

Regulatory Affairs

Affiliated Services

CSC Ltd. is able to offer clients additional capabilities by augmenting our in-house services with those of our affiliated partners to be able to provide:

 

Central Laboratory Services:

AML is Israel’s largest private full-service clinical laboratory located in the Herzliya Medical Center (a leading Israeli private hospital).
 
AML Israel is internationally accredited by ISRAC (the Israeli Laboratory Accreditation Authority) under the ISO 15189 International Standard.  AML successfully participates in multiple international quality control schemes – proficiency testing. AML Israel has an independent Quality Assurance Department with a Proprietary Quality Manual and document & version controlled written Standard Operating Procedures. AML has global alliances with 4 major international central labs including Esoterix Clinical Trials Services – a Labcorp Company, Eurofins-Medinet, Interlab International and LabConnect for standardized central lab services on multi-national clinical trials.

CSC Ltd. and AML have collaborated successfully on numerous clinical trials in the past.

Additional information  can be found on AML's website: www.aml.co.il  or phone Dave Shafir, General Manager, 972-9-9561268 ext. 106.

 

Data Management

CSC Ltd. does collaborates tightly with the client preferred Data Management vendor. In Israel Medistat Ltd. is the main supplier for DM and statistical analysis for studies managed by CSC Ltd. CSC Ltd. ensures that the DM services are efficient and appropriate.

Data Management vendors which collaborate with CSC Ltd. supply the following services:

 

  • CRF and database design
  • AE and medical coding and reporting
  • Internet-based randomiging system
  • Clinical trial safety database
  • Lab data import
  • Double data entry
  • Electronic data capture (EDC)
  • Query generation
  • Data validation, storage and archiving
  • Biostatistics

 

Additional information can be found on Medistat's  website: www.medistat.co.il or phone Gil Harrari, CEO +972-3- 6444465.

 

Translation Services

Translation is required at many stages in the course of bringing a drug to market, including clinical research, regulatory submissions, manufacturing, marketing and packaging. Thus, when it is required by company policies or SOPs, certified translating companies are used. The most common languages required in Israel are Hebrew, Arabic, and Russian. The typical documents we translate for our pharmaceutical and biotechnology industry clients include:

 

  • Package and Product Inserts and Labels
  • Patient Questionnaires
  • Consent Forms
  • Patient Information / Leaflets
  • Regulatory documents

 

Pharmaceutical and Medical Devices Distribution

Any Investigational Product must be imported  to Israel  in compliance with local MOH regulations. CSC Ltd. collaborates with leading pharmaceutical distributors in Israel such as IMP and Trialog. These serve as the local depot for many local and multinational pharmaceutical and CRO companies operating in Israel. Their’s expertise is in handling and abiding by specific local regulatory requirements and logistics.
 
Trialog can be contacted via:  http://www.trialog.co.il/
Boaz Gershon, General Manager

 
IMP can be contacted via:  http://imp-services.co.il/
Amir Malka, CEO, +972-50-2663899