With a tailored approach, our solutions have the capacity to fortify research programs of all sizes and structure.
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.
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
Institutional Review Board/ Ethics Committee submissions and communication
Study feasibility, start-up, maintenance, and close-out activity management
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
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