Clinical trials involve a myriad of complicated processes and variables. PKNM Solutions can help you navigate the clinical trial process to save you time and minimize costs.
Our Emphasis and Expertise is on preventing the need for identifying and solving the gaps of Clinical Trials: Protocol design, Clinical regulatory support, Statistical support, Submissions regulatory support and Data standards.
The need for clinical trial research on a given health problem – or the perceived need for such research – is only partly determined by the burden of disease posed by the problem. The severity of the corresponding product shortfall, the state of the relevant science and technology and disease trends can also affect the need for clinical trial research. In other words, the need for R&D will be relatively high for diseases for which effective product development has been scant and for emerging diseases, diseases posing increasing burdens and diseases on course for eradication, whereas clinical trials may be considered premature if basic science is lacking in new research areas. Caution is therefore warranted in interpreting the correlation – or lack of correlation – between the number of clinical trials conducted on a particular disease and the burden posed by that disease.
To date, very little reliable information has been produced on how much clinical trial research is being conducted in vast Therapeutic areas in several countries and how and if the results have been used properly.
With CROs we help differentiate their service offerings to their pharmaceuticals, medical devices and biotech clients in early evaluation of risk and opportunities in their intended trials and/or product placement/marketing.