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”, published in Hematology in which APICES has collaborated in study setup, coordination and project management, monitoring, data management, statistical analysis and manuscript.…
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 tumors: the GREKO (Granulosa Et Ketoconazole) trial, GETHI 2011-03”. published in Clinical and Translational Oncology in which APICES has collaborated in project…
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 with you. APICES in CTO Europe 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
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…
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, speakers, sponsors and attendees. Inicio – I Congreso de la FETTCC (fundacionttcc.com)
This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial”. published in…
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 mg once daily and 100 mg once daily as preemptive treatment for skin toxicity in patients with metastatic colorectal cancer treated with an anti-EGFR and chemotherapy” published in Supportive Care in…
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 application has been approved for the years 2022, 2023 and 2024. This approval recognises APICES’s ability to carry out R&D work on behalf of clients. APICES will…
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 with Muscle-invasive Urothelial Cancer of the Bladder”. This is an extra motivation for the whole APICES team. These achievements would not be possible without the involvement of every…
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 in localized prostate cancer (DART 01/05): 10-year results of a phase 3 randomised, controlled trial”. This is an extra motivation for the whole APICES team. These achievements would not be…
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,…
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 leukemia”, published in Medicine International in which APICES has collaborated in several tasks of the project as design, setup, coordination and project management, monitoring, statistical analysis and preparation of the manuscript. This…
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 with Cancer Pain Diagnosed with Opioid-Induced Constipation-The NACASY Study”, a study in which APICES has participated in study design, setup, coordination and project management, monitoring, statistical analysis…
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 of the first-line anti-TNFα used for the treatment of IBD: Results from the VERNE study”, a study in which APICES has participated in study setup, design, monitoring, data management, statistics…
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 in patients with a recent diagnosis of schizophrenia: a real-world observational prospective study”, published in Expert Opinion on Pharmacotherapy, a study in which APICES has participated in study setup, project…
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 Patients with Fibromyalgia and Associated Gastrointestinal Symptomatology; A Randomized Double-blind Clinical trial” published in Pharmaceuticals related with one study which APICES has collaborated in the statistical analysis. We…
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…
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 observational studies with medicinal products for human use in the spanish clinical trials registry, as we mentioned in a previous post. Thus, the AEMPS with the aim to facilitate this process…
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 are not a code of conduct geared to Contract Research Organization (CRO). EUCROF has been working in a “Code of Conduct for Service Providers in…
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 January 2022. In order to comply with the schedule, the European Commission must verify that all Clinical Trial Regulation have been met and publish the outcome in…
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…
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 gemcitabine in elderly patients with previously untreated locally advanced or metastatic pancreatic adenocarcinoma: the BIBABRAX study» published in Cancer Chemotherapy and Pharmacology and related with one study conducted by APICES, which has…
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…
This month, we want to share the acknowledgment that APICES has received in the recent publication titled “A decade of changes in management of immune thrombocytopenia, with special focus on elderly patients” published in Blood Cells, Molecules, and Diseases in which APICES has collaborated in several tasks of the project. This means an extra motivation…
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…
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 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…
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 across the globe simultaneously share campaign materials on their social media channels, with the hashtag #MedSafetyWeek. The campaign of this year focuses on…
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…
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 changes in daily processes in order to enhance working results and follow the evolution of clinical research. For this reason, on November 12th 2019, AECIC…
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 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…
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 were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the…
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 their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…
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 Clinical Trials. The E8 last version was adopted in 1997, but changes to trial design and conduct in the last two decades have made much of the guideline out…
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 that APICES has received in a recent publication in The Oncologist. This means to all APICES team an extra motivation in order to give continuity to the implication we…
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 Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014 (when come into force).…
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 cell therapy produced at Hospital Puerta de Hierro from Madrid, Spain. The medical team from Hospital Puerta de Hierro started working in NC1 20 years ago.…
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 perspective. In this document, a complex clinical trial is considered to have a complex clinical trial design if it has separate parts that could constitute individual…
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 (FDA) has revised the previous guidance on oncology endpoints published in May 2007. This guidance provides recommendations to applicants on endpoints for cancer…
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 projects and challenges for 2019. Moreover, 2019 is really a very special year, APICES will be 10 years old, in which APICES has not stopped growing and…
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 human persons study, complies with several ethics requirements stablished in The Helsinki Declaration. All clinical trial protocol should be evaluated by…
The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain. Annex II. Security documentation that the sponsor must send to the Health Authorities of the Autonomous Communities Annex V. Model of insurance certificate Annex VIIIC. Instructions for updating the section of Protection of personal data in the patient…
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 care institutions and are used to deliver care. The EHR systems can be an interesting chance in clinical investigation: to improve data accuracy and promote clinical…
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 global del beneficio de tratamiento que está siendo estudiado y de su relación beneficio- riesgo; pueden ser de dos tipos: Aquellos que, como los…
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 en la Unión Europea. Esto implica que según lo que establece el Real Decreto 577/2013, por el que se regula la farmacovigilancia de medicamentos de…
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 en la Unión Europea, fue aprobado por el Parlamento Europeo en abril de 2016, su ámbito de aplicación se extiende a todos los países miembros de la Unión Europea…
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 Cancer Research y la FDA utilizaron las recomendaciones del trabajo original de ASCO para identificar los criterios de elegibilidad que con mayor probabilidad restringirían la participación de los…
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 general de APICES, reflexionó sobre las debilidades y fortalezas de los End Points en Oncología Médica, sobre la interpretación…
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 (R1), los ensayos clínicos se realizaban en un proceso básicamente basado en papel. Los avances en el…
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 16 de abril de 2014, que deroga la anterior Directiva 2001/20/CE y en España, el Real Decreto…
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 alto impacto en la salud. Los nuevos Reglamentos, todavía no publicados, son documentos de alta complejidad técnica,…
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 a la hora de emitir facturas por participación-colaboración en estudios clínicos, aunque la recogida de datos clínicos…
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 sin la implicación de cada miembro del equipo en cada proyecto en el que colabora. Desde APICES…
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 conseguirse estos logros sin la implicación de cada miembro del equipo en cada proyecto en el que…
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 estudio donde se desarrolla el protocolo hasta el informe estadístico final debe existir una buena comunicación e…
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 los “riesgos” que se van a asumir en el proyecto que deben quedar claramente definidos y documentados en…
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 Organization). En APICES, como empresa comprometida en ofrecer a sus clientes los máximos estándares de calidad en…
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 uno de los proyectos en los que colaboramos. Desde APICES estamos muy orgullosos por el reconocimiento de…
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 los máximos estándares de calidad, APICES se enorgullece de ser la primera CRO (Contract Research Organization) en…
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 revistas científicas es la correcta descripción bibliográfica de las fuentes de información utilizadas para elaborar sus contribuciones.…
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 todos los integrantes del equipo, desde el paciente, pasando por el investigador y su equipo de investigación,…
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 de congresos, publicaciones de nuevas normativas y en general todo aquello que pueda considerarse de interés para…
