Click here to request a detailed quotation for drug packaging, labeling, storage, and distribution services in a clinical trial. The cost of packing, labeling, storing, and distributing a drug...
Click here to request a detailed quotation for the manufacture of a drug product batch for your clinical trial The cost of manufacturing a drug product batch is an important factor when calculating...
Pharmaceutical formulation is an important challenge faced by biotech companies developing new drugs to be tested in first-in-human (FIH) clinical trials. Formulation development is a fundamental...
Contact us at info@sofpromed.com if you need an EDC system for your clinical trial. An electronic data capture (EDC) system —also referred to as electronic case report form (eCRF)— is a very...
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 —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...
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...
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...
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...
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...
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...
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...
Contact us at info@sofpromed.com if you need an oncology CRO in the United States. Contract research organizations (CROs) are companies specialized in managing clinical trials. Although many CROs...
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...
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...
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)? A Contract Research Organization (CRO) is a company that provides specialized research services on a contract basis for the pharmaceutical,...
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,...
Contact us at info@sofpromed.com if you need CRO services in the United States. Which are the top clinical research organizations (CRO) in the United States? The top clinical research organizations...
Oncology-focused CRO will use TrialMaster EDC to support clinical data management services for sponsors in the oncology sector, particularly in phase I-IV cancer trials FORT LAUDERDALE, FL, December...