LinkedIn Posts
SMED Clinical Research is now operational
20/03/2024
A big thank you to everyone supporting us.
Introducing SMED Clinical Research's Featured Feasibility Process.
26/03/2024
At SMED Clinical Research, we understand that successful clinical trials start with meticulous site selection. That's why we've developed our Featured Feasibility Process, a comprehensive approach designed to streamline site identification and ensure the success of your study.
Review on FDA meetings
08/04/2024
FDA meetings are critical for effective communication and collaboration between sponsors and regulators. Understanding the different types of FDA meetings and their purposes is essential to successfully navigate the regulatory pathway. By leveraging these meetings appropriately, sponsors can address key issues, receive valuable feedback, and ensure a smoother drug development and approval process.
CTIS SUBMISIONS
12/04/2024
After publishing our review on FDA meetings, we had planned to delve into insights about the European regulatory environment, including how to request scientific advice and navigate the clinical trial application process. However, due to the vast scope and complexity of these topics—ranging from seeking advice from the EMA to individual country-specific processes—we decided to begin with a focused overview of the Clinical Trials Information System (CTIS), deferring other topics for subsequent discussions.
STATISTICAL DESIGNS FOR PHASE 1 TRIALS
15/04/2024
Optimizing phase 1 study designs in Oncology is crucial for efficient and effective clinical development, advancing new treatments while minimizing the time, resources, and sample size required for completion. Expedite dose selection and improve patient safety is key.
Overview of the 10 drugs that generated the highest revenue globally in 2023
2/5/2024
Our insightful data and financial analyst, Manuel López Romero, has curated a review spotlighting the top ten revenue-generating drugs of 2023.
As we eagerly anticipate our forthcoming review, let us reflect on the profound impact of accelerated development pathways, paving the way for transformative therapies to reach those in need with greater speed and efficacy.
Once upon a time…abiraterone, from the rejection to revolution.
8/5/2024
In our previous post, we look at the top 10 revenue-generating drugs of 2023, and their clinical development journeys. Yet, beyond these high-profile successes, there's a trove of other drugs that, for various reasons, have lingered in development limbo, been shelved, or perhaps haven't received the precise clinical attention they deserve.
Something like this happened with the drug that revolutionized the prostate cancer treatment landscape many years ago: abiraterone (Zytiga).
Accelerated approval procedure for trials conducted solely in Spain.
28/5/2024
Spain has been traditionally considered as an appealing country for running clinical trials, and it's not hard to see why, as it offers a highly favorable regulatory environment, generally short startup times, and centers with extensive experience that not only meet recruitment expectations but also ensure data quality; in short, a very efficient environment.
Elevate Your Clinical Trials with EMA's Groundbreaking Initiatives
19/06/2024
Expanding your clinical trials to include European countries has always been a smart strategy. Now, the European Medicines Agency (EMA) offers two new pathways to streamline the process and elevate the quality of your applications.
Great initiative from Agencia Española de Medicamentos y Productos Sanitarios, showing on a monthly basis the workload and availability for each Spanish EC.
5/8/2024
Stats Drops - Estadística descriptiva
12/08/2024
Introducing SMED's STATS DROPS Program!
At SMED, we're thrilled to launch of our new STATS DROPS program, designed to help you master various statistical concepts.
Whether you're curious about understanding a p-value, interpreting a Hazard Ratio, or diving into advanced topics like calculating sample sizes for different types of studies or understanding the impact of censored data, we've got you covered.
Our statisticians Ana Navarro Sellés and Manuel López Romero will be sharing short slide decks explaining all these topics, in an easily understandable way.
We'll be starting from the basics, and today, we're excited to share our first lesson on descriptive statistics with you.
Nuevos sistemas de EDC para estudios promovidos por investigadores
19/08/2024
En SMED Clinical Research entendemos las necesidades únicas de los investigadores. Por eso lanzamos un servicio especializado de cuaderno de recogida de datos (CRD) para ayudarte a gestionar tus datos de manera eficiente y profesional. ¿Estás desarrollando una base de datos para tu tesis, una revisión de casos, o un estudio promovido por tu centro o grupo cooperativo y necesitas asistencia con el manejo de datos? .
Unlocking Real Value Beyond Speculation
22/8/2024
While standard reports often rely on published trial results—which, though valuable, may not always reflect future success, particularly in early-phase studies—we delve deeper. Our approach involves evaluating the genuine medical interest, real-world potential, and likely revenue streams of a drug.
Our analysis integrates rigorous risk assessment and financial modelling. We consider various scenarios to gain a comprehensive view of potential profitability, and the risks associated with each project.
Simplifying Manuscript Preparation for Medical Journals
27/8/20224
Writing and submitting manuscripts to medical journals can be a daunting task. Questions often arise: which journal is the best fit? How should the statistical analysis be conducted? How can I ensure the document is edited accurately? What does the submission process entail?
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We continue to move forward with SMED's STATS DROPS program!
21/9/2024
After the success of our first lesson on descriptive statistics, we are pleased to present the second installment: hypothesis testing.
Registering your company as a Small and Medium-sized Enterprise (SME) with the European Medicines Agency (EMA) opens the door to numerous valuable advantages.
30/9/2024
We bring you a new post from the SMED STATS DROPS program!
4/11/2024
After our lessons on descriptive statistics and hypothesis testing, we are pleased to present the third installment: ANOVA.
3rd multi-stakeholder meeting of the EU-Innovation network!
6/11/2025
Hosted by AIFA Agenzia Italiana del farmaco, this event provides an open forum to exchange views on how innovation in ATMP development can be translated into accessible treatment options for patients across Europe.
We bring you a new post from the STATS DROPS program by SMED!
12/12/2024
After our lessons on descriptive statistics, hypothesis testing, and ANOVA, we're excited to present the fourth installment: Hazard Rate.
SMED Clinical Research has been officially recognized and registered as an SME by the EMA
29/12/2024
SMED Clinical Research is now Small-Medium-Company registered by European Medicines Agency. EMA provides extremely valuable support to SMEs; another reason to develop your clinical trials in Europe.
Spain has once again become the country with the greatest capacity to attract clinical research into medicines in the European Union. According to the Spanish Registry of Clinical Studies (REec), the Spanish Agency for Medicines and Health Products (AEMPS) authorized a total of 930 studies last year, thus becoming the European regulatory agency that has approved the most clinical trials.
9/1/2025
The ACTEU initiative (Accelerating Clinical Trials in the EU) is empowering SMEs to enhance expertise and innovation in clinical trials. A brilliant effort by European Medicines Agency, driving progress in the healthcare sector. We're excited to be a part of it—see you there! Cooperative groups, don´t miss the opportunity! This is a great support for academia as well.
15/1/2025
Calling academia and micro, small and medium-sized enterprises (SMEs) involved in the development of medicines for human use.
15/1/2025
EMA via the Accelerating Clinical Trials in the EU initiative (ACTEU) is taking concrete steps to build a comprehensive clinical trials training curriculum tailored to different audiences.
ICH Releases E6(R3) Guideline on Good Clinical Practices
20/1/2025
The International Council for Harmonization E6(R3) guideline introduces updates to modernize clinical trial standards, emphasizing risk management, data governance, and process efficiency.
European Medicines Agency
31/1/2025
From today, all Clinical Trials in the EU are governed by the Clinical Trials Regulation. The Clinical Trials Information System (CTIS) now supports submission, assessment and oversight of all trials in the EU.
EudraCT: Managing Clinical Trial Applications & Results Posting
11/2/2025
EudraCT's role has shifted with the adoption of CTIS, but it continues to be used for certain key functions, including the submission of clinical trial results by sponsors.
SMED Clinical Research at ASCO #GU25
18/2/2025
SMED has attended American Society of Clinical Oncology (ASCO) GU 2025, a key event in genitourinary oncology. As always, this conference has been an incredible opportunity to reconnect with colleagues, collaborators, partners, clients, investigators, and old (but still young) friends.
Medical Monitoring at SMED: Ensuring Quality and Compliance in Clinical Trials.
24/2/2025
With extensive expertise in Medical Monitoring, SMED Clinical Research provides support for clinical trials from Phase I to registration studies, ensuring patient safety, data accuracy, and regulatory compliance.
AEMPS organizes an informative session to present the new guide on Decentralized Elements in Clinical Trials.
24/2/2025
📅 Date: March 4, 2025
💻 Event: Online (registration required)
📒 Guidance: https://lnkd.in/dpWGuFMMm.
CTIS Updates: A New User-Friendly Way to Locate Clinical Trials.
3/3/2025
The ACT EU Trial Map is officially launching on the CTIS public portal on 3 of March!
Statistical training
8/3/2025
In this session we will focus on essential statistical concepts in the development of clinical trials:
Block I: Descriptive Statistics
Block II: Inference: Hypothesis Testing and ANOVA
Block III: Survival Analysis
Block IV: Scaling: 3+3 and BOIN
This is how our Training Session on Statistical Analysis in Clinical Research started last 8th of March.
Undoubtedly, your enthusiasm and participation made this experience even more special.
10/3/2025
The European Commission is calling on entrepreneurs, investors, and professionals to contribute to the development of the EU Startup and Scaleup Strategy, a plan to foster a more innovation-friendly environment across the Single Market.
11/3/2025