The Spanish Agency for Medicines and Health Products (AEMPS) has introduced an accelerated evaluation process (fast-track) to enhance Spain’s appeal for research on innovative medicines. This process will reduce the timelines for studies meeting the following criteria: Interested…
According to Farmaindustria, Spain is the European country with the highest participation in clinical trials. Of the 1,944 clinical trials authorized in the European Union through the new European Information System (CTIS), Spanish sites participated in 845 (43%).…
This month, we want to share the acknowledgment that APICES has received in the recent publication of an international clinical trial, titled “Atezolizumab plus bevacizumab and chemotherapy for metastatic, persistent, or recurrent cervical cancer (BEATcc): a randomised, open-label, phase…
This month, we want to share the acknowledgment that APICES has received in the recent publication titled “Phase II Trial Evaluating Olaparib Maintenance in Patients with Metastatic Castration-Resistant Prostate Cancer Responsive or Stabilized on Docetaxel Treatment: SOGUG-IMANOL Study”, published…
EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information…
Call for all sponsors to publish clinical trial results in EU database The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of…
ICH Releases Draft Revision of E8 Guideline, General Considerations for Clinical Trials Since the last update of ICH6 (R2) on 2017, ICH was working on a new release, a new revision of ICH E8 about General Considerations for…
Acknowledgment for APICES collaboration in a clinical trial published in The Oncologist. Many times the work of CROs is not totally acknowledged. But, fortunately, this is not always the case. This month, we want to share the acknowledgment…
CTFG KEY RECOMMENDATIONS TO CONDUCT A COMPLEX CLINICAL TRIAL The Clinical Trials Facilitation and Coordination Group has drawn up a document that provides recommendations for sponsors regarding the authorization and conduct of complex clinical trial from a current…
Use of electronic health record data in clinical investigations Electronic health record (EHR) systems are electronic platforms that contain individual health records for patients. EHR systems are generally maintained by health care providers, health care organizations, and health…
