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Invima certifica por tercera vez a la Unidad de Estudios Clínicos FCV en Buenas Prácticas Clínicas
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La Unidad de Estudios Clínicos de la FCV obtuvo nuevamente la certificación en Buenas Prácticas Clínicas por parte del Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), una acreditación que estará vigente por cinco años y que avala su capacidad para desarrollar estudios clínicos conforme a los más altos estándares de seguridad, ética y calidad.
Este reconocimiento, que se otorga por tercera vez, posiciona a la institución como una de las ocho en todo Santander autorizadas para realizar investigaciones con medicamentos, consolidando su rol como pionera y referente regional en investigación clínica.
Actualmente, la Unidad lidera 33 estudios clínicos dirigidos a población pediátrica y adulta. De estos, 11 se encuentran en fase de reclutamiento y 22 en etapa de seguimiento, abarcando áreas como oncología, cardiología, neurología, neumología, gastroenterología, medicina interna, hematología, nefrología, hepatología y vacunación.
Rigor científico y compromiso con los pacientes – Buenas practicas clínicas
De acuerdo con el doctor Diego Gómez Abreo, oncólogo y director de la Unidad de Estudios Clínicos FCV, “el proceso de evaluación del Invima es riguroso, ya que implica demostrar no solo la seguridad del paciente, sino la cultura de calidad continua que se refleja en cada etapa del estudio, desde la selección de participantes hasta el seguimiento clínico”.
Agregó que “este logro nos llena de orgullo. Nos posiciona como referentes en la región y refleja los resultados en salud que hemos alcanzado a lo largo de más de una década, impactando positivamente la vida de cientos de pacientes con patologías como insuficiencia cardíaca, cáncer de próstata, enfermedad inflamatoria intestinal, cefalea, entre otras”.
Por su parte, Doris Moreno, enfermera y jefe administrativa de la Unidad, destacó: “Este reconocimiento es de los pacientes, que han confiado en nosotros al participar en cada estudio. También es fruto del compromiso constante de médicos, investigadores, coordinadores y todo el equipo, que aporta su conocimiento y experiencia para hacer posible una investigación clínica ética, rigurosa y orientada a ofrecer nuevas alternativas de tratamiento”.
Más de 25 años de experiencia y más de 5.000 participantes
La trayectoria de la Unidad de Estudios Clínicos FCV supera los 25 años y ha incluido la realización de más de 150 investigaciones clínicas en alianza con la industria farmacéutica. Durante este tiempo, más de 5.000 personas han participado en estudios, accediendo a servicios como asesoría médica especializada, seguimiento clínico, pruebas diagnósticas y exámenes de laboratorio.
El modelo de atención, centrado en la confianza y el respeto por el paciente, ha permitido mantener altos estándares de calidad y generar aportes científicos relevantes que contribuyen al avance de la medicina.
Comité de Ética también obtiene certificación
El compromiso con la integridad ética también se evidencia en el Comité de Ética en Investigación de la FCV, que recibió igualmente su tercera certificación por parte del Invima. Esta validación reconoce su labor independiente y rigurosa en la revisión, evaluación y seguimiento de cada estudio, asegurando el cumplimiento de las normativas nacionales e internacionales.
La doble certificación, tanto de la Unidad como del Comité de Ética, ratifica el enfoque institucional de la FCV: investigación clínica con excelencia, transparencia, respeto y responsabilidad hacia los pacientes y la comunidad científica.
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