Clinical Trial Management
Our versatile and dynamic operational approach, together with a pool of highly motivated in-house Clinical Research Associates, enables us to overcome even most complex challenges and help you meet milestones.
Advancing your goals
We’re constantly adjusting and developing new, inventive delivery methods to keep you one step ahead. In addition, we have a wealth of expertise in various therapeutic areas and across all clinical development disciplines.
Managing clinical trials is just as much about the people involved for us as the numbers. Therefore, we offer Clinical Research Associates who work with you and your team on-site. Their understanding of legal requirements, compliance, and policies, as well as their enthusiasm, energy, and devotion, make them an excellent choice to ensure your Clinical Development reaches its full potential.
Our CRO services are executed through our affiliated company CRES. We also offer:
Trial Design
Improving your trial design this way ensures reliable data transmission and minimizes changes to your clinical development plan and subsequent delays.
While clinical development might be daunting, Isheo’s insight on patient outcomes can optimize your clinical development by applying a risk- and data-driven mentality. We start design with access in mind.
Contract Negotiation
Participating in clinical trials also entails developing an effective budget and contracting procedure. We offer insight into negotiation processes and enable investigators and sponsors to work together to bring novel medicines to patients.
Isheo’s clinical development expertise and negotiation abilities may assist you in obtaining the most favourable clinical trial agreements, budgets, and fair, effective contracts.
Clinical Monitoring
Isheo’s clinical monitoring and site management services are customized to your trial’s specific needs.
Our specialists supervise the whole trial and ensure that it is conducted, documented, and reported in line with the study protocol, standard operating procedures (SOPs), good clinical practice (GCP), and relevant legislation.
Clinical Project Management
Our Clinical Project Managers are in charge of the planning and coordination of clinical studies including pharmaceuticals, medical devices, and diagnostics.
By maintaining a constant focus on the trial’s status, we can trust and confidenly answer to any clinical questions, achieve timelines, and exceed expectations.
Biostatistics
Valid statistical design, data analysis, and transparent reporting all contribute considerably to the quality of your clinical research.
Isheo’s biostatistical assistance elucidates the origins of diversity in patients’ treatment responses. We enable scientists to draw plausible and reliable conclusions from acquired data and to make informed choices in the face of ambiguity using biostatistics.
Medical Writing
The medical writers at Isheo help you create well-structured scientific documentation for your clinical trials.
Our regulatory medical writing support ranges from preparing regulatory documents for national authorities and local ethics committees to the documentation needed throughout your clinical study.
Training
We regard training as an essential step to help you reach your growth objectives. We aim to be the best in clinical research research teducation and, for us, training is an integral part of advancing clinical development.
Clinical Research and Education Services is a division of Isheo that specializes in developing and delivering theoretical and practical training for clinical trials of pharmaceuticals and medical devices.
“Leave nothing to chance for your Clinical Trials. “
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