An emerging biotech pharmaceutical company conducting a Phase II study aimed to achieve set-up in three months and enroll 120 patients with a tight timeline. The company partnered with Evestia Clinical to manage these timelines and requested that Evestia Clinical work with the selected sites.
The Evestia Clinical project team coordinated a flexible and expedited setup of the systems, database, and vendors, and had the sites activated on time. Enrollment was completed ahead of plan for both cohorts.
The Evestia Clinical team provided training for the sites and maintained a flexible approach to ensure that data monitoring and cleaning remained up-to-date. Their emphasis on site training, quality, and data integrity contributed significantly to a highly successful outcome. The database was locked on time, allowing the statistical team to conduct the required analysis seamlessly.
The company was able to use the positive preliminary analysis to support its clinical development plans. As of today, the partnership is ongoing, with a Phase IIb study in the start-up phase and another one in a different indication planned for later this year.
About the authors
Silvia Centenera
Silvia is a seasoned clinical research professional with over twenty-five years of experience, four in pharma and over 20 in the CRO arena. Silvia has extensive global team management and operational knowledge gained through several years of holding leadership roles within project management and clinical operations. She has been responsible for the oversight and successful delivery of clinical trials in a variety of therapeutic areas, with special focus in oncology and rare disease. She has been directly involved in the first stages of the clinical development of innovative biologicals, including monoclonal antibodies, and gene and cell therapy.
Kirstyn Warren
Kirstyn is an enthusiastic and analytical UK-based Project Manager, with 4 years of CRO project management experience, in phase I-II oncology, ophthalmology, gastroenterology, rare disease, type II diabetes, natural history and validation trials. She has led several projects and programs across Sponsor-dedicated portfolios, led her project team through client audits, and facilitated an expedited study start-up, involving a record ePRO 2-week set-up time. Kirstyn is highly organised and has a close attention to detail in her documentation, demonstrated by her achievement of the Gold Award in the PharmaTimes International Clinical Researcher of the Year Clinical Trial Administrator category. Her adaptability and dedication to delivering operational excellence are invaluable in her delivery of high-quality projects, which she considers to be essential in building and maintaining her strong client relationships.
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