We inform our Clients of strategic and quality approaches to expedite clinical development.
How do we do this?
We have the knowledge and expertise to guide the navigation of the right path for our Clients' product through the ever changing global regulatory environments. To ensure acceptability of individual studies and overall development plans by global regulatory authorities and potential corporate partners, we inform on industry best practices and the standards required by Australian, US and European Regulatory Authorities.
We respect the insight and intelligence that Key Opinion Leaders (KOLs) bring to clinical development and utilising our network of contacts, as needed, we can identify KOLs in a given field of medicine, or work closely with the Clients’ KOLs to assist in the provision of clinical study expertise in a specified therapeutic area.
We are able to provide recommendations or develop a bespoke Quality Plan for our Clients’ needs dependent on the stage of development and business model. We provide gap analyses on existing standard operating procedures (SOPs) to determine how best to achieve an appropriate compliant quality system, and as needed, develop or provide the tools required to fill any gaps.