Karma Cardiology understands that sponsors may not want to outsource their whole clinical trial but do still need some support in its design and planning. In response to that, we provide consultancy services such as clinical development planning, study design and budget preparation.
Karma Cardiology knows that cardiology trials are complex, thus all of our project managers and CRAs have cardiology clinical trial experience. Our local knowledge of sites and investigators around the globe means we can manage risks and suggest innovative solutions.
We are flexible and will perform the complete clinical trial or any part of it, for example: monitoring a single site.
EXPERT PROJECT MANAGEMENT – our Project Managers and Project Directors provide sponsors with outstanding operational expertise based on their experience leading complex phase I – III cardiology studies. Activities include comprehensive feasibility studies, site selection, ethics and regulatory submissions, project management of all aspects of the trial.
SITE MANAGEMENT AND MONITORING – CRAs are local to their sites and in our experience, local knowledge and continuity are critical to the relationship with sites.
MEDICAL WRITING – protocols, informed consent documents, clinical study reports, investigator brochures, abstracts, posters and manuscripts can be prepared by our experienced team.
INVESTIGATOR PAYMENTS – can be facilitated through our offices to avoid delays.
CLINICAL DATA REVIEW – Continuous review of CRF data is conducted by an experienced team of trained team members. Quality issues that may not be readily apparent to data management or CRAs are identified early such that corrective actions can be implemented without delay. Clinical Data Review ensures adherence to the protocol (including toxicity grading and response evaluation criteria).
Effective use of Clinical Data Review enables data clean-up to be performed on an ongoing basis by looking at the patient data across time and ensuring that the final data makes medical sense. We have found that this approach has been very beneficial to our sponsors by avoiding delays and allowing databases to be locked as early as possible (1 – 5 days) after last subject, last visit.
RESCUE STUDIES – We are able to step in to evaluate, diagnose and implement solutions to various challenges of ongoing cardiology studies including delayed study start-up, slow enrollment, data collection issues, lack of site engagement and inconsistent or ineffective project management.
DATA PRIVACY MANAGEMENT – provided to ensure compliance with the EU Directive
EUROPEAN LEGAL REPRESENTATION– this is provided through Karma Cardiology (Europe) Ltd., headquartered in Dublin
Other services, for example, data management, statistics, pharmacovigilance and medical monitoring are provided through trusted partners.
- We offer the same team from start to finish of a project; there is no continual handover from one team to another
- Simplified processes rather than multiple systems and processes save time and money without compromising quality.
- We never forget that the study belongs to the sponsor.
- Sponsor timelines are respected and adhered to.
- Communication is key to a successful partnership.
- Our CRAs are “professional” CRAs which provides stability