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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

Download BROCHURE

Global Median Beat (GMB)

Download OVERVIEW SHEET

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Our Medical Imaging team is in the spotlight for a job well done! https://t.co/fkmt0zvPhf https://t.co/D7YMTeiSd3
bioclinica (2 days ago)
RT @melfass: "What this agreement means is that we can allocate scarce resources to areas of higher risk" @US_FDA on MRA with @EMA_News at…
bioclinica (3 days ago)
RT @DrugInfoAssn: What has been the biggest takeway for your organization so far? Tweet @ us using #DIA2017
bioclinica (5 days ago)
"Q" on #RBM & Total Quality Mgmt? @Kristin_Mauri has "A" @DrugInfoAssn #DIA2017 https://t.co/MqCxkmAfa0
bioclinica (5 days ago)
Kristen Mauri shows the @DIA audience the value of risk based monitoring https://t.co/ssJCfc9gQ5
bioclinica (5 days ago)
Innovation Theater Kristin Mauri of @bioclinica presenting on RBM & TQM @DrugInfoAssn #DIA2017 https://t.co/zsGroQcpiU
bioclinica (5 days ago)

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