Services
For Sponsors:
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We can provide bespoke Clinical Trial Management support to meet your needs.
Our main consultant has over fifteen years experience working on international PII-III trials ensuring Good Clinical Practise and adherence to the protocol for Biotechnology and Pharmaceutical Clinical Operations throughout Europe, North America and Asia Pacific.
Example Clinical Trial Manager (CTM) Roles include:
CTM to ensure alignment between operations in Japan and the Global study.
Additional CTM support during study start up in Japan.
CTM for Asia/ Pacific Operations.
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No matter how well the operations of a trial is going, it is recommended to have an independent assessment of the Clinical Research Organisation (CRO) oversight and Clinical Research Associate (CRA) proficiency. We will review adherence to the Clinical Monitoring Plan, ICH-GCP and the Study Protocol.
Site visits are conducted alongside our bilingual (English/ Japanese) Medical Doctor to ensure complete understanding of the source.
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Issues can and will happen. We are prepared to get up-to-date at speed and support you with co-monitoring or project management support short term or until the operations are back in balance.
For Clinical Research and Medical Professionals:
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Gain confidence in your ability to communicate in English and become an engaging presenter.
We focus on preparing and conducting mock meetings.
AI is becoming a useful tool but presenting in front of a fluent English speaker is by far still the best practise.
Creating clear engaging presentations that translate complex data into captivating slides so that colleagues and stakeholders can understand the facts clearly. This allows the most productive conversations to take place.
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Be ready to put your best self forward.
When prepared, an interview can go from being a stressful event to an exciting career opportunity.
We focus on being clear on your story and experience.
It might seem redundant to focus on your own experience because no one knows it better than you!? But how often do we come out of interviews and think “oh I wish I said this” or “ I forgot to mention this project - it was a perfect example to answer that question”.
Know your experience inside out and have considered your experience in relation to the role you are interviewing for.
We will ensure you are prepared.