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  • As a top Clinical Research Organization, ProPharma brings over 20 years of experience, innovation, personalization, and adaptability to Sponsors’ studies and research.

  • Australia is a preferred destination for early phase trials because of simple and fast regulatory stream and lucrative R&D cash refund scheme.

  • At ProPharma, our Cell and Gene Therapy consulting team offers a comprehensive and integrated approach to early-stage cell and gene therapy development. Our expert team provides a range of services, including IND/CTA preparation, manufacturing technology, safety and risk assessment, and development planning, to help our clients navigate the complex and ever-changing landscape of cell and gene therapy development.

  • The full-service Contract Research Organization (CRO) with operations in Australia, New Zealand, Asia, North America, and Europe.

  • A global team of trusted experts for multi-phase clinical development.

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Clinical trials
Clinical trials refer to any research done in any medical field. The main objective of clinical research is to find solutions to better screening, preventing, diagnosis and treatment of diseases. Trends such as clinical trial globalization have been credited for the increased dominance of these trials in the medical field. Pharmaceutical companies have stepped a notch higher by not limiting their trials to their native countries. North American companies have moved to Asia and Eastern Europe since these areas offer lower costs and higher patient numbers.
Globalization comes with its own challenges since one has to conform to the regulatory standards set by the individual regulators in the new areas they venture into. The research infrastructure in some of these areas is not up to a similar scale to that in the areas a manufacturer operates in. Intellectual property ownership and biospecimen ownership might be issues that can lead to delay in commencement. These complications along with ethical issues might be limiting factors.
Clinical trials usually occur in three phases. The first phase involves human testing. This is important in establishing the amount required as dosage. The second phase involves accessing if the administration has an effect in relation to what is being tested. For instance, the second phase in cancer trials determines the anti-cancer effects of an administration. The last phase involves comparing the patients using a tested treatment with those in the standardized treatments.
Though some people are still skeptical about clinical trials due to the uncertainty, there are numerous others who are willing to participate in these trials. The principle investigators and their team are responsible for ascertaining the safety and the risks involved in a trial. One needs not to be worried since these professionals have credentials that will be applied in ensuring safety of all the participants.