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

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.

RT @virtue_insight: #VIphv We are delighted to announce our new Gold Sponsor @bioclinica for our 16th Pharmacovigilance 2018 https://t.co/h…
bioclinica (4 days ago)
RT @bioclinica: Tackling the costly issue of drug supply waste in clinical trials. Find out how Novo Nordisk & other global pharmas R embra…
bioclinica (4 days ago)
Tackling the costly issue of drug supply waste in clinical trials. Find out how Novo Nordisk & other global pharmas… https://t.co/iW7Q9DfVgQ
bioclinica (2 weeks ago)
Background & key considerations to help #pharma prepare for new FDA blood pressure draft guidance issued in May. Ac… https://t.co/07dJeeD35E
bioclinica (3 weeks ago)
Tackling the costly issue of drug supply waste in clinical trials. Find out how Novo Nordisk & other global pharmas… https://t.co/tSx5tm2rgg
bioclinica (4 weeks ago)
DYK @bioclinica offers full-svc global clinical data mgmt svcs customizable to your study & program needs? Our high… https://t.co/dyXDiCtWd8
bioclinica (4 weeks ago)

Latest Blogs:

Blood pressure monitor
Prescription box
Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations