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 tumors. Check this information about clinical trials for these tumor types.
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...
Spain is a great country to conduct clinical trials. By the end of 2018, according to ClinicalTrials.gov, the American database of clinical studies carried out worldwide, Spain is the fifth European...
There are several types of electronic data capture (EDC) solutions that can be used to manage data in clinical trials. The selection of the data management tool will depend on the size of the study...
An eCRF (electronic case report form) is a software system used to collect data in a clinical study. Commonly, eCRFs are web-based applications containing various data forms and fields designed to...
Cleaning data in clinical trials can be a tedious task when the electronic case report form (eCRF) has not been properly designed. Identifying and resolving discrepancies in data is a...
The term "quality", when talking about clinical trials, is related to various elements and concepts. But what are the basics of quality that any clinical trial should meet? On what grounds is...
Sofpromed, a full service contract research organization (CRO) focused on cancer trial management, has announced the extension of its clinical operations to provide local service in additional...
Clinical trials involve several regulatory affairs before, during, and after the research. In Spain, trial sponsors need to interact with the ethics committee (EC) and the competent authority (CA),...
Sofpromed is a full-service contract research organization (CRO) headquartered in Spain. Thanks to its location, Sofpromed can provide local clinical trial management services in Spanish cities, for...
International multisite trials are complex and costly. Large numbers of hospitals and patients cause practical challenges.