Bioforum | Data Masters

MEET THE
DATA MASTERS

Drug Development is moving to the next phase of clinical data services where you stay with ONE data partner throughout the clinical development process. A partner that thoroughly knows and understands your data and is fully committed to your long terms goals.

OUR SERVICES

Clinical Data Managment

A Medidata Rave® partner, we offer all data management services from CRF design to database lock

Biostatistics

As a key component in Bioforum’s services, we offer indication-specific biostatistics expertise tailored to your study needs

Clinical Programming

As the largest group within Bioforum and a CDISC Registered Solution Provider since 2009, we provide diversified SAS programming services tailored to customer needs

Medical Writing

Bioforum partners with Sponsors to create the highest-quality clear, concise, regulation-compliant documents delivered within Sponsor-defined timelines.

Pharmacovigilance

Bioforum provides a wide range of PV services throughout the different regions and for all phases of clinical trials

Regulatory
Insight

SEND – Overview in Light of FDA Requirements

SEND (Standard for Exchange of Nonclinical Data) is a means of implementing CDISC Standard Data Tabulation Model (SDTM) to represent nonclinical data. SEND standards are based on SDTM domains and variables and include…

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Study Data Standardization Plan – Importance and Advantages

The SDSP (Study Data Standardization Plan) is a document intended to communicate to CDER (Center for Drug Evaluation and Research)  and CBER (Center for Biological Evaluation and Research)  the expected CDISC…

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At a Glance – What’s New in the FDA Technical Conformance Guide Version 3.3

The FDA has recently published a new version of the Technical Conformance Guide (TCG) with updates that impact regulatory data submissions. Technical Rejection Criteria Presenting the Technical Rejection Criteria is one…

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QUALITY

Bioforum is ISO-9001:2015 Certified

Our services and the utilized technologies are compliant with GCP/ICH and 21 CFR Part 11,as well as with different privacy laws. Moreover, Bioforum is a CDISC registered Solutions Provider and our data management personnel are members of the Society for Clinical Data Management (SCDM). Data management activities are performed according to GCDMP (Good Clinical Data Management Practice) guidelines.

We are committed on meeting the quality and performance expectations of our clients whilst adhering to all relevant regulatory requirements. The maintenance of a comprehensive Quality System is central to our ability to meet these expectations.

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EDC To SDTM

In Less Than One Day

STAY IN TOUCH

BIOFORUM LTD.
T. +972-8-9313070
F. +972-8-9313071
info@bioforumgroup.com