by Patricio Ledesma | Mar 9, 2019 | CRO Spain
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, and academic research sponsors to conduct their clinical trials in...
by Patricio Ledesma | Mar 1, 2019 | Rare Cancers
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 information about rare cancers, and particularly on clinical trials...
by María José López | Feb 27, 2019 | Quality
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 compliance with the protocol, Standard Operating Procedures (SOP), Good...
by Patricio Ledesma | Feb 15, 2019 | Clinical Trials Spain
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. As explained in the article “Nine reasons to conduct an oncology...
by Patricio Ledesma | Feb 14, 2019 | Clinical Trials Spain
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 becomes particularly important if the clinical study is conducted in a...
by Patricio Ledesma | Feb 13, 2019 | Clinical Trials Spain
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 country (taking into account the United Kingdom) with more clinical...
by Patricio Ledesma | Feb 10, 2019 | Clinical Data Management
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 and the functionality needed. It is very important that a detailed...
by Patricio Ledesma | Feb 10, 2019 | Clinical Data Management
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 receive data in clinical trials or observational studies. eCRFs are...
by Patricio Ledesma | Feb 10, 2019 | Clinical Data Management
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 resource-consuming activity, particularly when multiple queries are to be issued to...
by Patricio Ledesma | Feb 4, 2019 | Quality
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 quality based when we talk about drug-related clinical trials?...
by Anita Pacharazova | Feb 3, 2019 | News
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 countries in Europe, namely Portugal, France, Italy, Germany, and Bulgaria....
by Patricio Ledesma | May 28, 2018 | Regulatory Affairs
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), namely the Agencia Española de Medicamentos y Productos Sanitarios...
