PKNM Solutions Sàrl

It is the mission of PKNM Solutions to establish and manage international public-private partnerships in pursuit of innovative, multidisciplinary R&D for safe and socially treasured therapeutic solutions.The PKNM Solutions team can help develop and implement a clear development and regulatory pathway for the most innovative and complex pharmaceutical and biotech products. 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 diPKNM Solutions' experience in streamlining processes, knowledge management, integrating use of web-based technology, data warehousing, data mining and use of data reporting tools have helped many Medical Affairs groups become high-performance organizations. We help our clients achieve the operational excellence that gives them the competitive edge needed in today's marketplace.Our emphasis is on consulting relating to quality, nonclinical and clinical aspects, both from the perspective of development strategy and regulatory requirements. PKNM Solutions has the knowledge and experience to assist at all stages of product development, from conception to registration, and beyond. With regulatory agencies, we have been working to compare "trial populations" with the real world population because of their concerns about post-approval risk.

• Employees 3
• Founded 2014