Comparator Network

TransCelerate’s Comparator Network establishes a reliable, rapid sourcing of quality products for use in clinical trials for participating Member Companies to avoid counterfeiting and avoid delays in study start-up.

Rationale

Overview

Pharmaceutical companies spend millions each year purchasing commercial marketed products for use in clinical studies. Supply chain intermediaries can decrease security, introduce delays, and cannot provide access to key drug documentation.  With a decreasing supply, increasing demand, and cost of these “Comparators”, there is opportunity for a counterfeit issue to arise.

To address this need, TransCelerate’s Comparator Network provides an established channel through which participating Member Companies can reliably and rapidly source quality comparator products from each other for use in clinical trials.

Impact

The Comparator Network has allowed Member Companies to reliably and rapidly source quality products for use in clinical trials, ultimately enabling accelerated trial timelines and enhanced patient safety.

The success of the Comparator Network has laid the foundation for the sharing of materials beyond commercial product such as bulk drug product, and blinded active and placebo. These newly expanded exchanges reduce clinical trial costs and complexity, decrease the risk of unblinding, and improve patient safety by ensuring that comparators are used in their intended presentations.

The Comparator Network also helps enhance patient safety due to known source of materials and comparator drug documentation. It limits the chance for counterfeits to enter the investigational supply chain and allows for the continuity of drug supply for products used in studies.

Benefits

  • Enhanced patient safety due to known source of materials and comparator drug documentation
  • Limited chance for counterfeits to enter the investigational supply chain
  • Allows for the continuity of drug supply for products used in studies

Available Solutions

Access to the Comparator Network is provided for TransCelerate Member Companies only.

Related Initiatives

Clinical Content & Reuse

What is Clinical Content & Reuse (CC&R) Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R. The Clinical Content & Reuse (CC&R) Initiative enhanced clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project…

Historical Trial Data Sharing

The Historical Trial Data Sharing (Controls) Initiative was established to enable the sharing of data to maximize the value of clinical data collected historically in the placebo and standard of care control arms of clinical trials.

Clinical Data Standards

Clinical data are reported by individual trials in various ways which may cause a labor intensive process to gain data insights. The Clinical Data Standards Initiative, in collaboration with CDISC (Clinical Data Interchange Standards Consortium), C-Path (Critical Path Institute), NCI- EVS (National Cancer Institute – Enterprise Vocabulary Service) and FDA as part of the CFAST (Coalition For Accelerating Standards and Therapies), aims to develop industry-wide Data Standards in priority Therapeutic Areas (TAs) to support the exchange and submission of clinical research and metadata, while improving patient safety and clinical trial outcomes.