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Protocol Design and Expert Reporting

Study design and Consultative Services

In this highly dynamic and competitive business environment, it is important to have a partner that can help you successfully navigate through the complex drug development process. Whether your team is ready to conduct your company's first TQT study, needs assistance in determining study design options and technology for defining a blood pressure signal for your protocol, or advanced training on medical imaging best practices, Bioclinica can help. We provide a full range of consultancy and reporting services supporting cardiovascular safety throughout the clinical development of your compound.

Our services include:

  • Expert protocol development and study design
  • Statistical analysis plans
  • Expert summary reports for inclusion in the Clinical Study Report
  • Regulatory guidance and support
  • Charter development

Bioclinica is committed to providing you with the highest level of service. The team assigned to your cardiac safety study will provide expert advice on clinical and regulatory strategy, tailored to the framework of your program and specific compound. Engage our team of experts early to assist in developing an effective, comprehensive drug development program and trial protocol.

Cardiac Safety Analysis and Expert Reporting

Bioclinica recognizes the need to provide comprehensive services from study design and conduct to expert reporting of cardiac safety data. We possess strong capabilities in analyzing and presenting ECG/ABPM/CV data in regulatory, expert report format, and we support regulatory meetings and presentations. Our statistical and medical writing team has authored more than 250 expert reports, most of which supported regulatory submissions and full TQT protocol development.

ADDITIONAL RESOURCES

Cardiovascular Solutions

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Global Median Beat (GMB)

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Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

ICYMI: Take a look at Bioclinica Clinical Adjudication that caught the judges' eye in the recent Scrip Awards. It's… https://t.co/gPk4aLmTuA
Bioclinica (2 weeks ago)
Still time to catch up with Aina Lihn, Kathleen Kane, Anette Vierning and other Bioclinica folks at #PCTRIALS https://t.co/E3qxdjqTV5
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Awesome day 2 at #PCTRIALS in Barcelona! Great to connect w new & long-time partners & #lifescience clients! https://t.co/ElM3VPCoSk
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Great talk by @bioclinica's CIO & EVP Technology Gavin Nichol at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/geIjGIFL06
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Great talk by @bioclinica's CIO & EVP Technology Gavin Nichols at #PCTRIALS 2018 on #FDA recent guidance on EHR EDC… https://t.co/agqP32q09W
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Ask us about technology-enabled clinical development powered by science! Hear our CIO in a day 2 talk. See… https://t.co/iZyF8ixV79
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