ADaM (Analysis Data Model) is the standard designed to ensure that analysis datasets are reproducible, reviewable, and traceable from tabulation (SDTM) to statistical results.
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El escenario regulatorio de las Terapias Avanzadas es complejo. En él conviven autorizaciones de uso hospitalario con medicamentos plenamente aprobados por la EMA. Entender esta dualidad permite anti...
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La presión por acortar los tiempos de desarrollo y mejorar el acceso temprano a medicamentos innovadores ha impulsado a Europa a reforzar y ampliar sus vías aceleradas. En los últimos año la EMA h...
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Managing a clinical trial with a limited population requires rethinking many of the usual assumptions of clinical research. When the number of potential patients is small, every methodological, operat...
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In the day-to-day conduct of clinical trials, one of the factors that most strongly affects patient recruitment and retention is not the scientific design of the protocol, but rather the indirect fina...
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The way a clinical trial is communicated to patients determines its viability from the very outset. Before assessing inclusion criteria or protocol complexity, patients need to understand what is bein...
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It has been driven the adoption of digital archiving systems, known as eTMF or electronic Trial Master File. However, the transition from a paper-based TMF to an eTMF should not be understood merely a...
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Las crisis no deben paralizar la investigación, pero tampoco justificar atajos que pongan en riesgo a los participantes o la validez de los resultados. Este es el leit motiv de la nueva guía de la E...
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La selección de centros en oncología es uno de los factores que más influye a la hora de acortar los tiempos de un ensayo clínico. Por ello, elegir bien dónde abrir un ensayo es casi tan crítico...
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Making reimbursement of expenses or compensation for loss of productivity reach the patient in clinical trials can sometimes pose a major obstacle to the daytoday operations of hospital sites. At the ...
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ABE Capital and Columbus Venture Partners have reached an agreement to acquire a majority stake in Sermes CRO, a Spanish contract research organization specializing in end-to-end management of clinica...
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What happens when a clinical trial fails to comply with regulations? Fines, delays, and loss of credibility are just the tip of the iceberg. In a sector where patient safety and scientific integrity a...
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La mejor actitud que podemos adoptar es la de trat...
The research team observed changes in head circumf...
AtCDF3 gene induced greater production of sugars a...
En nuestro post hablamos sobre este interesante tipo de célula del...
El galardón convierte a Oryzon en una de las cinco ganadoras de la pr...
