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How are clinical trials conducted? What is a CRO? Read our articles and learn more about clinical trials and contract research organizations.
List of European Contract Research Organizations (CRO) for Clinical Trials (Part 2)
Here you can find a complete list of small and medium-sized full-service European clinical research organizations (CROs) managing phase I-IV clinical trials across different therapeutic areas. This...
List of Clinical Research Organizations (CRO) for Clinical Trials in Europe (Part 1)
Here you can find a comprehensive list of small and medium-sized European contract research organizations (CROs) specialized in clinical trial management. These are full service CROs focused on...
What is an Electronic Data Capture (EDC) System in Clinical Trials?
An electronic data capture (EDC) system —also referred to as electronic case report form (eCRF)— is a very important software tool in clinical trials. Clinical research relies on accurate data and...
How Much Does an Electronic Case Report Form (eCRF) Cost?
Click here to download a fully detailed Electronic Case Report Form (eCRF) quote An Electronic Case Report Form (eCRF) software —also known as Electronic Data Capture (EDC) system— is an essential...
Post-Approval Studies (PAS) with Drugs in Europe: Frequently Asked Questions
Post-approval studies —also known as postmarketing or post-authorization studies— are important clinical studies conducted by biotech and pharma companies once a drug has obtained a marketing...
European CDMOs for Small-Batch Manufacturing and Sterile Fill-Finish of Injectable Drugs for Clinical Trials
Download a list of flexible European CDMOs for small-batch sterile manufacturing of injectable drugs, with full contact information. Non-EU biotech companies running clinical trials in Europe...
25 Tips for the IMPD Quality Section: Guidance for Clinical Trials in Europe
The quality section of the Investigational Medicinal Product Dossier (IMPD) —which deals with the chemistry, manufacturing, and controls (CMC) of a drug— is a very critical factor to have a clinical...
What Are the Documents Required for Clinical Trial Applications to Regulatory Authorities in Europe?
Biotech and pharma companies planning clinical trials in Europe will have to submit a clinical trial application (CTA) to the national regulatory authorities of the countries in which the clinical...
Navigating the Early Stages of Drug Development: Key Advice for Biotech Companies
Michael Loftus is the Executive Director of Integrium Clinical Research, a clinical CRO headquartered in California, United States, specialized in executing phase I, II, III, and IV clinical trials...
How to Develop a Clinical Trial Budget: Download Excel Worksheet
This article explains how to develop a per patient clinical trial budget (test, procedure, and staff costs to be paid to the hospital for each recruited subject). If you want to download a free (per...
CRO for Clinical Trials in Europe: Expert Guidance for U.S. Biotech Companies
U.S. biotech companies often have the need of conducting clinical trials in Europe. Planning clinical studies in the European Union poses several operational and regulatory challenges, like finding...
QP Declaration: Conducting Clinical Trials in Europe with Drugs Manufactured in Non-EU Countries
Biotech and pharma companies conducting clinical trials in Europe —with a drug product (DP) manufactured in a non-EU country— will need a Qualified Person’s (QP) Declaration when submitting the...
Oncology Contract Research Organizations (CROs) in the United States
Contract research organizations (CROs) are companies specialized in managing clinical trials. Although many CROs manage clinical studies across multiple diseases, some CROs have particular...
Top 5 Contract Development and Manufacturing Organizations (CDMOs)
What is a CDMO? CDMO stands for Contract Development and Manufacturing Organization. A CDMO is a company dedicated to providing drug development and manufacturing services for the pharmaceutical and...
Phase 1 Clinical Trials: Frequently Asked Questions
What is a phase 1 clinical trial? A phase 1 clinical trial is a clinical study in humans that seeks to evaluate the safety (toxicity) of a new drug (or combination of drugs) and its maximum...