Clinical Operations in Oncology Trials Europe 2022

APICES is actively participating in the upcoming CLINICAL OPERATIONS IN ONCOLOGY TRIALS EUROPE 2022 congress in Zurich. In the following link you can access the agenda. Clinical Operations in Oncology Trials Europe 2022 On November 23rd, Ana Moreno, Director Global Clinical Operations at APICES, will give us her opinion regarding how to succeed in your…

Acknowledgement for APICES collaboration in INMUNOSUN study published in «ESMO Open»

We are privileged to share the acknowledgment that APICES has received in the recent publication titled: “Results from the INMUNOSUN-SOGUG trial: a prospective phase II study of sunitinib as a second-line therapy in patients with metastatic renal cell carcinoma after immune checkpoint-based combination therapy”, a study in which APICES has participated in study design, setup,…

Acknowledgment for APICES collaboration in a GICOR trial published in Radiotherapy and Oncology

From APICES, we are privileged to share the acknowledgment that we have received in the recent publication titled “Prognostic value of testosterone castration levels following androgen deprivation and high-dose radiotherapy in localized prostate cancer: Results from a phase III trial” published in Radiotherapy and Oncology. We would like again to thank Almudena Zapatero and GICOR…

CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING

Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014. The implementation to a European level implies a Harmonization of the submission of a clinical trial from all Member States of the part I documentation: documentation to…

New regulation for observational studies with medicines for human use in Spain

Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE. This regulation will come into force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into account the observational nature of these type of studies with drugs that…

Acknowledgment for APICES collaboration in DUTRENEO study presented as ORAL PRESENTATION at ASCO 2020 Annual Meeting.

We want to share the acknowledgment that APICES has received in a recent ORAL PRESENTATION at the ASCO 2020 Annual Meeting by Dr. Enrique Grande. APICES has participated in medical writing monitoring, project management, safety, data management and statistics of the DUTRENEO study. This means an extra motivación to all APICES team in order to give continuity to the implication we…

Acknowledgment for APICES collaboration in a clinical trial published in Scientific Reports.

This month, we want to share the acknowledgment that APICES has received in a recent publication in Scientific Reports in which APICES has collaborated in several tasks of the project. This means to all APICES team an extra motivation in order to give continuity to the implication we have in every project in which we…