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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.
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...
How Much Do Phase 1 Clinical Trials Cost in the United States?
Click here to get a fully detailed phase 1 clinical trial quote Biotech companies developing new drugs carry out phase 1 clinical trials to test the safety and preliminary efficacy of their...
What is a Contract Research Organization (CRO)?
What is a Contract Research Organization (CRO)? A Contract Research Organization (CRO) is a company that provides specialized research services on a contract basis for the pharmaceutical,...
Pivotal Clinical Trials: Frequently Asked Questions
What is a pivotal clinical trial? A pivotal clinical trial is a clinical study seeking to demonstrate the efficacy of a new drug in order to obtain its marketing approval by regulatory authorities...
How to Select a Clinical Research Organization (CRO)
Which are the criteria to choose a Clinical Research Organization (CRO)? Key criteria to select a CRO include its service catalog, experience, knowledge of the disease, access to patients,...
Top Clinical Research Organizations (CRO) in the United States
Which are the top clinical research organizations (CRO) in the United States? The top clinical research organizations (CRO) in the United States are Covance (LabCorp), IQVIA, Syneos Health, PPD, PRA...