O2 Clinical Research, LLC
a fresh breath in research

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

 

Business Development, Contract Negotiation, and Finance

A research program needs quality clinical trial opportunities. Sponsors have a number of ways they select which investigators and sites they will work with on any particular study. An investigator’s interest is not enough. Our connections with business development partners and established relationships act as the main driving force to match exciting study opportunities to clients. We market each client’s strengths and capabilities as it applies to a given study. We also advise clients on the acceptance or declination of an opportunity if it will not serve in the best interest of their program overall.

Once a client is accepted by a sponsor, we analyze each protocol against the proposed budget to ensure the best possible compensation is negotiated. We also ensure contract language is sound and discuss any concerns with the client for possible negotiation.

We also track patient activity during a study to ensure proper payments are received by study sponsors. We provide transparent financial reporting to each client on a regular basis.


Regulatory Affairs

Regulatory compliance and management is the framework within which medical discovery moves. It serves as an interface between regulatory authorities and study teams conducting clinical trials ensuring patient safety, quality data, and ethical practices. It is no small feat. Left in inexperienced or lax hands can jeopardize entire programs leaving investigators vulnerable and without the trust of sponsors to return to their site with new studies. The direct experience and knowledge O2 has amassed over time in this heavily regulated industry is paramount to the services our clients can expect such as:

  • Building and maintaining site and investigator dossiers

  • Creation, updating, and training of Standard Operating Procedures

  • Safety reporting

  • Institutional Review Board/ Ethics Committee submissions

  • Study start-up, maintenance, and close-out document submission and filing


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 which study sponsors can then analyze and report on. 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

  • Scheduling of clinic and ancillary visits

  • Source document creation and amendments

  • Lab set up, management, and shipping of samples

  • Drug storage, dispensing, and destruction/return

 

Our solutions include full service and ala carte options.