Please Wait...

Bioclinica Cardiac Safety Services Offered a Unique Solution for a Specific Regulatory Requirement

A small biopharmaceutical company that focuses on therapeutics in immune disorders was developing an oral therapy to treat relapsing multiple sclerosis. During the development of this therapy an off-target effect of bradycardia occurring up to 6 hours after the dose was identified. To meet regulatory requirements for phase 2/3 trials to evaluate efficacy and safety of the drug, heart rate (HR) needed to be monitored via ECG by a centralized lab for a minimum of 6 hours after the dose. After HR normalized at the 6-hour timepoint the patient could be discharged from the neurology clinic.

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
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.

Changes are a fact of life - and of #clinicaltrial design. But that doesn't mean planning and budgeting for your tr… https://t.co/BUPFjuIXOt
Bioclinica (Yesterday)
Bioclinica announced today that the company has contributed data to the primary efficacy endpoint in more than 200… https://t.co/8epFHqKFcL
Bioclinica (6 days ago)
No change order fees for new clients with our #RTSM platform means fewer hurdles as you race to study start. Ready… https://t.co/Z5AOtkWT3e
Bioclinica (2 weeks ago)
With over 25 years of experience in Cardiac Safety monitoring services, Bioclinica is a recognized global leader in… https://t.co/CMY48C4QVR
Bioclinica (2 weeks ago)
Bioclinica is an agile organization with more 2,300 colleagues around the globe - and growing! Learn more here.… https://t.co/oLPRURkhm7
Bioclinica (3 weeks ago)
Going to DIA Japan in Toyko? Meet our team at booth 47! https://t.co/X1jTu0UbUb https://t.co/vwKvUUbarp
Bioclinica (4 weeks ago)