Clinical trials are one of the more expensive parts of clinical development, and nowadays not only are they needed to prove safety and efficacy before obtaining marketing approval for a drug or a medical device, but health care payers, insurers, state agencies, patient representatives, and others, seek evidence that the drug has a positive impact for patients’ health or, at least, quality of life.
The trial design thus gets more and more complicated, which in turn again rises the price of clinical trials.
ProjectPharm has a unique approach to overcome this spiral, which we called the “virtual CRO”. By virtual we mean, that we buy each individual service from the most appropriate vendor, be it regulatory affairs, monitoring, medical monitoring and pharmacovigilance, technology (IWRS, ePRO etc.), data management, statistics, etc., to compose the best possible project team for your clinical trial.
We ensure that the project plan encompasses all aspects required by the respective guidelines and laws, as well as regulatory authorities, in terms of regulatory and quality requirements, and thus form a CRO, built around your particular project.
Depending on your business needs, we would select vendors based, e.g., on their specific competences, capabilities, geographic reach, or pricing model, to ensure that you get exactly what you need for the best price available on the market.
We used this model already in the year 1997, at the time imposed by the sponsor, but never as systematically and successfully as with ProjectPharm.