Clinopo is a group of Clinical Research Professionals working with Sponsors who need support operating clinical trials in Japan.

We are not a CRO.

Services

For Sponsors:

  • 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.

  • 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.

  • 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:

  • Gain confidence in your ability to present in English and become an engaging presenter.

    The ability to present and communicate through English can further your career options.

    We focus on,

    • Gaining confidence in your abilities.

    • Practise, practise, practise (!) in front of a fluent English speaker.

    • Creating clear engaging slides translating complex data into captivating slides so that colleagues and stakeholders can understand the facts clearly. This allows the most productive conversations to take place.

  • 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,

    • Gaining confidence in your abilities

    • Practise, practise, practise (!) in front of a fluent English speaker.

    • 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.

Operationally there are nuances to Japan, we have seen the following have a positive impact on clinical operations:

  • EXAMPLE OF WORK

    CLIENT BRIEF

    Japanese CRO is a different CRO to Rest of World CRO. The time difference coupled with the thoroughness of the Japanese team was becoming a PM role in itself.

    WHAT WE PROVIDED

    Oversight of Japanese CRO while working closely alongside Sponsors Global PM, ensuring alignment with rest of world in real time (daily calls across all time zones).

    CLINOPO TEAM

    Clinical Project Manager (part time hours)

  • EXAMPLE OF WORK

    CLIENT BRIEF

    Per the Sponsors Quality Control procedure an independent audit of a Japanese Investigator Site was required.

    WHAT WE PROVIDED

    A two day audit of an Investigator Site reported in Japanese and English to allow for full understanding, discussion and implementation of recommended actions by all parties.

    CLINOPO TEAM

    GCP Auditor and bilingual Medical Doctor

  • EXAMPLE OF WORK

    CLIENT BRIEF

    Study start-up in Japan required an additional sponsor management resource to be available during Japanese working hours.

    WHAT WE PROVIDED

    A designated PM to see the project through start-up in Japan working closely alongside the Sponsor Global PM, dealing with CRO and site questions and delivering answers across international timezones in real time.

    CLINOPO TEAM

    Clinical Trial Manager (part time hours)

Our results speak for themselves - we have been hired multiple times by the people we have worked with previously.

Short term, part-time, full-time, a one off meeting - we are open to all.

The success of our support relies on continual consideration of the project. We keep this in mind throughout by ensuring in-depth conversations with you, our client, directly.

Projects change rapidly in today's world. We respond to change fast and allow for this when planning our workload.

CONTACT ❯
CONTACT ❯

Please feel free to reach out if you want to collaborate with us, or simply discuss a potential project.