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...
Clinical trial sponsors in the pharmaceutical and biotechnology industries planning to send study data to the U. S. Food and Drug Administration (FDA) during their drug development programs, must...
What is SDTM? SDTM stands for “Study Data Tabulation Model”, and is a CDISC standard to structure (tabulate) clinical trial data to be submitted to regulatory authorities such as the Food and Drug...
Oncology clinical trials are complex and sponsors should know in advance the key elements and local procedures that will be required to undertake such large, intricate, and demanding venture. This...
Spain is an excellent country to carry out clinical trials. According to ClinicalTrials.gov, the American database of clinical studies conducted around the world, by the end of 2019, Spain is the...
Europe, together with the United States and Asia, is one of the regions in the world where more clinical trials are carried out. Currently in the US database Clinicaltrials.gov, there are 65,572...
Sofpromed is a full service contract research organization (CRO) specialized in the management of phase I-IV clinical trials in Spain. In this article we describe how we help pharma, biotechnology,...
Rare cancers represent nearly 20% of all cancer cases. Many of them do not have effective treatments. Are there clinical trials for rare tumors? If you are looking for comprehensive and reliable...
According to ICH-GCP, section 5.19.1: “The purpose of an audit, which is independent of and separate from routine monitoring and quality control functions, should be to evaluate trial conduct and...
Speeding up clinical trial initiation Speeding up clinical trial initiation timelines is a very critical factor for study sponsors. Therefore, the faster a clinical study is initiated, the better....
Cancer clinical trials are complex and sponsors should know in advance the critical aspects and local procedures that will be needed to undertake such large and demanding venture. This knowledge...