O2 Clinical Research, LLC
a fresh breath in research

New Page

find what you need here

 

With a tailored approach, our solutions have the capacity to fortify research programs of all sizes and structure.

 
 
02E96639.jpg
 

Business Development, Contract Negotiation, and Finance

Our connections with business development partners and established industry relationships act as the main driving force to match exciting study opportunities to clients. We keep the research interests and goals of our our clients at the fore and market their strengths, experience, and capabilities.

We review each study’s contract and analyze proposed budgets against protocol so that the best possible budget is negotiated. Our tracking of patient activity, management of invoicing, and monitoring of sponsor payments is one of the many services we offer that provide relief for practice administrations.


ISS_4709_03001.jpg

Regulatory Affairs

Clinical research is framed by undeniable and non-negotiable standards, rules, and regulations to ensure patient safety, quality data, and ethical practices. Its’ management is no small feat. The direct experience and knowledge O2 has in this heavily regulated industry is paramount to the services our clients can expect such as:

  • Building and maintaining site and investigator dossiers

  • Creation and updating of, and training on Standard Operating Procedures

  • Safety reporting

  • Institutional Review Board/ Ethics Committee submissions and communication

  • Study feasibility, start-up, maintenance, and close-out activity management


ISS_10348_02443.jpg

Clinical Operations

Clinical trials, at its most basic level, looks to generate and capture data. These data become available thanks to the physicians who serve as investigators and their patient’s who volunteer. The proper and correct execution of a study protocol ensures quality data and patient safety. The coordination of a protocol is detailed and has many moving parts. Our team is well versed in these important activities such as:

  • Informed consent process

  • Protocol compliance

  • Source document creation and amendments

  • Clinical data capture

  • Data quality assurance reviews and audits

  • Lab set up and management

  • Drug/ Device storage, tracking, dispensing, and destruction/return

 

Our solutions include full service and ala carte options.