Driving Value ≡ Medical Excellence
Driving Value ≡ Medical Excellence
What We Do
Commitment to Driving Value
Our company recognizes that working collaboratively, medical teams drive the value of drug development and commercial activities through excellence in study strategy and medical affairs programs
Drug Development
With expertise especially in oncology and radiopharmaceuticals, our team provides ad hoc strategic guidance and oversight through to fractional Chief Medical Officer support.
Medical Monitoring
Our global team provides around the clock, 24/7 Medical Monitoring to ensure study deliverables are met and the quality of your clinical trial is maintained - putting patients first.
The Art of Medical Monitoring
What is Medical Monitoring
We see Medical Monitoring as the core medical oversight of a clinical trial by qualified physicians with expertise in pharmaceutical development, around the globe. ICH E6 Good Clinical Practice requires 24/7 medical oversight "The sponsor should designate appropriately qualified medical personnel who will be readily available to advise on trial related medical questions or problems".
Site Engagement and Interactions
A site-focused, proactive response to protocol queries maintains relationships with your study teams and ensures consistency in clinical trial execution. On-site visits with peer-to-peer discussions enable optimal recruitment and overcome challenges in study design.
24/7 Support: Putting Patients First
From critical care studies for enrollment or dosing decisions to being readily avaialble to advise a patient's non-study healthcare provider, such as an ER on a study medication, our physicians are available around the clock.
Eligibility and Data Review
Is the right patient entering the study? An enrollment review can reduce expensive study drop-outs and violations whilst ongoing CRF and data review improves data quality and monitors for safety signals.
Study Committees
Study steering committees, and data / safety committees such as IDMCs, DSMBs are important to be managed correctly by sponsor experienced medics.
Project Team
The Sponsor or CRO needs medical support they can trust from education in a therapy area, to protocol queries and regulatory engagement.