Please Wait...

Protocol Design and Expert Reporting

You are here

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 divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Smiles all around on Pizza Day today for @bioclinica eHealth in Audubon compliments of our CTO Andrew Masters. This… https://t.co/PbFoWnxn3B
bioclinica (17 hours ago)
Missed Tuesday's webinar on agile #IRT? No worries! Catch it here > https://t.co/kKUIQEB0vI #Pharma #CRO #eClinical
bioclinica (19 hours ago)
RT @ACROhealth: Where do you stand on regulating #mHealth & #Wearables in #clinicalresearch? w/ @bioclinica, @ICONplc, @INC_Research https:…
bioclinica (2 days ago)
RT @ACROhealth: ICYMI: @CCTAwareness’ Infographic on #clinicaltrials awareness for #Alzheimer’s and Parkinson’s treatments. https://t.co/84…
bioclinica (2 days ago)
RT @bioclinica: Culture of knowledge, passion, innovation. See what it means to work w industry's best. Explore @bioclinica Careers https:/…
bioclinica (2 days ago)
Thnx everyone who joined our agile #IRT webinar. And thnx to our presenters Amanda NIte, Ken Clark. https://t.co/Ff0WOczvsT
bioclinica (2 days ago)

Latest Blogs: