This month, we want to share the acknowledgment that APICES has received in the recent publication of LOADH Study: Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic small cell lung cancer: protocol for a…
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…
This month, we want to share the acknowledgment that APICES has received in the recent publication of SPASSET Study: Healthcare Resource Utilization and Associated Costs among Patient with Advanced Non-Small-Cell Lung Cancer Receiving Chemotherapy or Immunotherapy in Spain,…
The Clinical Trials Information System (CTIS) is the online system for the regulatory submission, authorization, and supervision of clinical trials in the European Union and the European Economic Area. CTIS is the single entry point for clinical trials in…
APICES attended the most important annual Biotechnology congress, BIO International Convention, which took place between June 3 and June 6 in the city of San Diego (CA – USA). The BIO International Convention is the largest and most…
This month, we want to share the acknowledgment that APICES has received in the recent publication of HEMOLIFE Study: Humanistic burden of haemophilia Awithout inhibitors: A cross-sectional analysis of the HEMOLIFE study, published in Haemophilia in which APICES has…
This month, we want to share the acknowledgment that APICES has received in the recent publication of RENO Study: Clinical characteristics, treatment patterns and survival results in patients with metastatic renal cell carcinoma in Northern Spain, published in Seminars…
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…
This month, we want to share the acknowledgment that APICES has received in the recent publication of COMISH study titled: “Real-world study on microsatellite instability and mismatch repair deficiency testing patterns among patients with metastatic colorectal cancer in…
This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the Geminis study”
Amelia Martín Uranga, Associate Director of Clinical and Translational Research at Farmaindustria, explains why Spain is an international leader in clinical trials. Spain is the second country in terms of investment by the pharmaceutical industry, behind the United…
APICES corporate video is available on the Clinical Trials Arena website Hi everybody, APICES corporate video is now also available on the Clinical Trials Arena website. Enjoy it! https://www.clinicaltrialsarena.com/contractors/clinical-trials/apices/#apices (select tab “videos”)
Spanish CRO APICES boosts its expansion and growth plans with the integration of the French CRO Kappa Santé. With this operation, the Spanish company will have offices in Paris (France), consolidating its growth and fostering collaboration with other research…
This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A glimpse into relapsed refractory multiple myeloma treatment in real-world practice in Spain: the Geminis study”
We want to share the acknowledgment that APICES has received in the recent publication titled “Open-label phase II clinical trial of ketoconazole as CYP17 inhibitor in metastatic or advanced non-resectable granulosa cell ovarian…
APICES speaking in CTO in Europe APICES speaking in Clinical Operations in Oncology Clinical Trials in Europe, Zurich. How to succeed in your oncology clinical trials from regional-medium CRO’S point of view. A pleasure to share our view…
Clinical Operations in Oncology Trials Europe 2022 Today starts Clinical Operations in Oncology Trials Europe. APICES is speaking about why medium/regional CROs are the best choice in Oncology trials. Clinical Operations in Oncology Trials Europe 2022
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…
First Congress Fundación Española de Tratamiento de Tumores de Cabeza y Cuello It is a pleasure for APICES to cooperate with this multidisciplinary congress in head and neck cancer where clinical research is a must. Congrats to organisers,…
Acknowledgement for APICES collaboration in study ABIDO published in ” European Journal of Cancer” This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A phase II randomised trial of abiraterone…
Acknowledgement for APICES collaboration in DERMIA study published in “Supportive Care in Cancer” This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A phase 2 study for evaluating doxycycline 50…
APICES approved by French Ministry of Research as research organization. We are very happy to inform you that APICES has applied to the French Ministry of Research as an organisation carrying out research and development (R&D) and this…
Acknowledgement for APICES collaboration in ABACUS trial published in “European Urology” Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “Final Results of Neoadjuvant Atezolizumab in Cisplatin-ineligible Patients…
Acknowledgement for APICES collaboration in DART 01/05 study published in “The Lancet Oncology” Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “High-dose radiotherapy and risk-adapted androgen deprivation…
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…
Acknowledgement for APICES collaboration in FDO-LMA-2016-01 study published in “Medicine International” This month, we want to share the acknowledgment that APICES has received in the recent publication titled “Biomarker-driven phase IB clinical trial of OPB-111077 in acute myeloid…
Acknowledgement for APICES collaboration in NACASY study published in “Cancers” Once more time we are privileged to share the acknowledgment that APICES has received in the recent publication titled: “A Prospective, Real-Word, Multinational Study of Naloxegol for Patients…
Acknowledgement for APICES collaboration in VERNE study published in “Digestive and Live Disease” We are privileged to share the acknowledgment that APICES has received in the recent publication titled: “Treatment patterns and intensification within 5 year of follow-up…
Acknowledgment for APICES collaboration in TIME study published in “Expert Opinion on Pharmacotherapy” We are privileged to share the acknowledgment that APICES has received in the recent publication titled: “Impact on functionality of the paliperidone palmitate three-month formulation…
Acknowledgment for APICES collaboration in PROBIOTIC trial published in Pharmaceuticals From APICES, we are privileged to share the acknowledgment that we have received in the recent publication titled: “Efficacy and Tolerability of the Probiotic VSL#3 for the Treatment of…
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…
GESTO platform: Publication of results of observational studies with medicinal products for human use After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of…
NEW DATA PROTECTION CODE OF CONDUCT BY EUCROF Procedure and technical measures in order to comply with General Data Protection Regulation 2016/679 are being more and more standardized through codes of conduct in several fields. Until now, there…
FINAL APPROVAL EU PORTAL AND DATABASE BY EMA’s MANAGEMENT BOARD Great news upcoming! Yesterday, EMA’s Management Board confirmed that the clinical trial EU Portal and Database, is now fully functional and on track to go live by 31…
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…
Acknowledgment for APICES collaboration in BIBABRAX Study published in Cancer Chemotherapy and Pharmacology Once again, we are privileged to share the acknowledgment that APICES has received in the recent publication titled “Phase II clinical trial of nab‑paclitaxel plus…
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…
Acknowledgment for APICES collaboration in a study published in Blood Cells, Molecules, and Diseases. This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A decade of changes in management of…
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…
Acknowledgment for APICES collaboration in STREAM study published in Clinical and Translational Oncology. This month, we want to share the acknowledgment that APICES has received in a recent publication in Clinical and Translational Oncology in which APICES has…
Raising pharmacovigilance awareness in the #MedSafetyWeek This week is the Annual Pharmacovigilance Week, organized by Uppsala Monitoring Center and led in Spain by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). For one week in November, medicine regulators…
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…
VIII AECIC SUMMIT: EU 536/2014 CLINICAL TRIAL REGULATION AECIC (Asociación Española de Compañías de Investigación Clínica/Spanish association of CROs) is aware of the continuous development and innovation in clinical research. Thus, it is necessary to include improvements and…
Acknowledgment for APICES collaboration in a clinical trial published in BMC Cancer. This month, we want to share the acknowledgment that APICES has received in a recent publication in BMC Cancer in which APICES has collaborated in several…
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…
AEMPS UPDATES GCP SECTION On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated: New version of serious protocol breaches notification form. Prohibition of FDA 1572 form in clinical trials carried out in…
NEW TREATMENT OPTION FOR PATIENTS WITH SPINAL CORD INJURY This month has been published a relevant article about a new therapeutic advance. A patient with spinal cord injury can walk again after being treated with NC1, a new…
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…
GUIDANCE ON ONCOLOGY ENDPOINTS: FDA REVISION Clinical trial endpoints serve to different objectives: In early phase, clinical trials evaluate safety and evidence biological drug activity; for later phase efficacy studies evaluate the clinical benefit. Food and Drug Administration…
MERRY CHRISTMAS AND HAPPY 2019 – APICES 10 YEARS OLD Next year is very close and is time to think about results of this year, time to celebrate successes and to be enthralled with the beginning of new…
BIOETHICS IN CLINICAL TRIALS The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the…
Update of Annexes II, V and VIIIC of the AEMPS for the conduct of clinical trials in Spain The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain. Annex II. Security…
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…
Endpoints en ensayos clínicos: Ventajas y desventajas Los endpoints primarios en ensayos clínicos deben basarse en 3 requisitos: Ser clínicamente relevantes. Relacionados con el efecto del tratamiento. Medibles e interpretables. Los endpoints secundarios pueden aportar una visión más…
Comunicación de Reacciones Adversas a Medicamentos a eudravigilance. Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos…
La protección de datos – Nueva regulación adaptada a la era digital El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas…
Actualización de los criterios de selección de pacientes en ensayos clínicos Estimados amigos, En el recientemente celebrado congreso anual de la Asociación Americana de Oncología Clínica (ASCO) se ha presentado un trabajo en el que ASCO, Friends of…
El VIII Seminario Fundación ECO, organizado de manera conjunta con la Real Academia Nacional de Medicina, ofreció un foro de debate y discusión en esta ocasión, sobre la evaluación y los resultados de salud en Oncología. Oscar Salamanca, director…
Desde la finalización de las Normas de Buena Práctica Clínica (GCP) de la ICH en 1996, la escala, la complejidad y el coste de los ensayos clínicos han aumentado. Cuando se preparó el texto original de ICH E6…
Los procesos excesivamente complejos y burocratizados, y la fragmentación de las autorizaciones entre las distintas autoridades a nivel europeo e interno son los principales óbices que intenta solventar el Reglamento 536/2014 del Parlamento Europeo y del Consejo, de…
Estimados amigos, La Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) ha celebrado el pasado 13 de septiembre una jornada informativa sobre los Nuevos Reglamentos Europeos de Productos Sanitarios que buscan reforzar las garantías sanitarias en productos de…
Estimados colaboradores, Este mes queremos hablaros de un tema de especial importancia a tener en cuenta si vais a recibir una contraprestación por participar o colaborar en un estudio clínico. Destacar la importancia en aplicar la normativa fiscal…
Estimados amigos, Mediante esta comunicación queremos haceros partícipes del reconocimiento que APICES ha recibido en una publicación reciente en Annals of Hematology. Esto supone una motivación extra para todo el equipo de APICES. No podrían conseguirse estos logros…
Estimados amigos, Mediante esta comunicación queremos haceros partícipes del reconocimiento que APICES ha recibido en una publicación reciente en International Archives of Allergy and Immunology. Esto supone una motivación extra para todo el equipo de APICES. No podrían…
Gran parte del éxito de un proyecto reside en una buena comunicación entre el estadístico y el investigador, entendiéndose como investigador coordinador, monitor médico o responsable médico del promotor, según aplique en cada estudio. Desde el planteamiento del…
Risk Based Monitoring (RBM) o Monitorización Basada en el Riesgo es un reciente método de trabajo que está cambiando el modelo de monitorización hasta ahora establecido. Las nuevas tecnologías facilitan la implantación de esta nueva metodología si bien exige un mayor detalle de…
La ISO 9001:2015 ya está aquí y son muchas las dudas que se nos pueden plantear. Una de esas dudas es si será rentable para las organizaciones que la implanten y en particular para una CRO (Contract Research…
Este mes queremos haceros partícipes del reconocimiento que APICES ha recibido en una publicación reciente en Lancet Oncology. Esto supone para todo el equipo de APICES una motivación extra para dar continuidad a la implicación tenemos en cada…
Nos es muy grato comunicar que APICES ha superado con éxito el proceso de auditoría necesario para obtener la certificación en la nueva revisión de la norma ISO 9001:2015. Siguiendo con el compromiso de ofrecer a nuestros clientes…
La US National Library of Medicine ha anunciado una nueva edición de las conocidas Normas De Descripción Bibliográficas Según El Estilo Vancouver. Una de las dificultades más frecuentes a las que se enfrentan los autores que escriben para…
La participación de nuestro país en ensayos clínicos (EECC) es una de las pruebas fehacientes de estar a la vanguardia de la investigación y desarrollo del I+D en el sector salud y una prueba de eficiencia y beneficio para…
Nos es grato presentar una nueva iniciativa de APICES. Se trata de un blog donde queremos aportar nuestro granito de arena a la distribución del conocimiento en investigación clínica, además de comentar los últimos avances en investigación, nuevos tratamientos disponibles, calendarios…
