Clinical trials team
Fatima-Zahra Agrad (BSc, PhD) is the Clinical Trial Department Head. Dr Agrad has joined Dynakin in 2010 first as a Clinical Assessor within the Drug Modeling & Consulting Department. Since 2014, Dr Agrad is the Clinical Trial Department Head and as such has participated in the design and protocol development of several clinical trials including bioequivalence trials, Phase 1, Phase 2 and Phase 3 studies in different therapeutic areas. Moreover, Dr Agrad has been involved in the resolution of post-submission regulatory and clinical concerns related to various MAA for NCE and generics. Fatima has also acted as a CTM in different Phase 1 and bioequivalence studies within DynaKin and has a previous experience as a CRA and CPL. She has complemented her career with a Degree in Business Administration for the Pharmaceutical Industry and specific Statistic courses.
Itziar Oteo (BSc, PhD) is our Data Manager and statistician for Phase 1 and bioequivalence studies. Itziar has joined DynaKin in 2005 first as GLP technician and moving to the Clinical Trial Department in 2011. As Data Manager she has participated in the design and protocol development of several clinical trials as well as in the elaboration of the data management documentation (including developing of the database (DB) clinical trial data specifications, CRF design, query logic and data validations) and clinical study reports. She has a broad experience in the use of pharmacokinetic and statistical tools within the frame of preclinical and clinical research. She has actively participated in numerous modeling projects and is the author of different scientific publications.
Ana Abaigar (BSc) is our Clinical Research Associate. She has complemented her career with a Masters degree in “Pharmacology, Development, Evaluation and Rational Use of Drugs” and specific CRA and GCP courses. Ana gives support to the different activities and projects within the Department and has participated in the design and protocol development of several clinical trials including bioequivalence trials and Phase 1 in different therapeutic áreas. She has monitored several clinical trials from different phases and therapeutic areas (SNC, oncology, cardiology, pain, dermatology, etc.). Ana is currently preparing her PhD in Pharmacy.