Please Wait...

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

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.

Attending CBI's IRT conf? Catch 10/27 @bioclinica GSK talk on bens of sponsor controlled #IRT. Here's the core tech… https://t.co/zFiQswIQFb
bioclinica (12 hours ago)
RT @Xtalks: #Cardiovascular Imaging for Monitoring Safety: Visualizing Outcomes @bioclinica https://t.co/5osqBkDFKm
bioclinica (13 hours ago)
Want stellar imaging acquisition & assessment in your #clinicaltrial ? Get tips in @bioclinica 's Tim Crowe's blog https://t.co/hzbV3Cmlyc
bioclinica (Yesterday)
Will you be at CBI's IRT conference in Philly Oct 26-27? https://t.co/C7vuxwnCH7
bioclinica (Yesterday)
Must-see live webinar packed w info for those who want to learn about CV safety from the leading experts.… https://t.co/4y5OaUNeIk
bioclinica (5 days ago)
Right at home near our Princeton offc is where to catch us talking all things #RTSM Oct.18-19.… https://t.co/h1OSFwiSFi
bioclinica (5 days ago)

Latest Blogs: