Clinical Development

Strategy

Poor strategic planning wastes time and money and can lead to the failure of a product that could help patients.  We are experts in all stages of drug development, with a history of success in getting products past milestones and onto the market.

We can develop a roadmap of activities needed to successfully gain marketing approval. However, we are not just a consultancy.  Therefore, we can implement any or all of the development processes for you, from pre-clinical and formulation advice, through clinical study design, regulatory processes and launch preparation.

We believe in continuity of relationships during the development process.  Our consultants are not just a separate group within Agos Pharma, they will be an intimate part of the development process, working with you in overseeing each step.

Feasibility & Site Selection

Studies that take too long cost more and threaten the success of the product.  Going to the top KOLs may help, but they may not be the best recruiters. Appropriate feasibility studies and site selection can aide rapid study recruitment and save costs by shortening the overall study duration, even if that means going to more sites and countries than originally envisaged.

We use software tools to aide initial targeting of regions, countries and sites.  After that, we don’t use simplistic online tools that were designed for mass market research and which may give a rapid answer, but an answer that is not always correct – meaning you waste time and money and possibly even the whole trial.  We use a well-tried proprietary system that, at the final analysis, uses contact with the site to ensure the most accurate data on which to make a decision.

Project Management & Implementation

How many times have you seen good CRO Project Managers taken off your project, just after you and your investigators have started to form a good relationship?  How many times have you seen CRAs come and go, often too inexperienced for the job?

Each change of PM or CRA requires more time and effort from you and poorer recruitment at site.  Many CROs believe in making a quick buck, rather than developing relationships.  Good relationships are essential to good study recruitment and conduct.  We keep your PM on your trial.  We can demonstrate higher rates of CRA retention on study than CROs, due to the use of experienced, responsible CRAs who are not stretched over too many studies and over too many sites.

We understand that your products are critically important to you and may represent hope to patients.  Therefore, you take your responsibility for study conduct very seriously.  ICH GCP guidance, as well as national and regional legislation makes it clear that the Sponsor is ultimately responsible for study conduct.

We also understand that you need to ensure studies are run effectively to hit timelines and budget – whilst meeting all the changing and critical national and regional legislation.

We can Project Manage this process for you, giving you one point of contact either regionally or globally.  We can either oversee your existing CROs, or implement studies ourselves using our European, and global, network of freelancers and affiliated groups.

Rescue Studies

Do you have a CRO that has overpromised?  Is their succession of PMs and CRAs damaging your trial and your company’s future? Are you seeing change order after change order because they deliberately underbid to get the trial, and now you have a big problem?

We have seen it all before.  We have also rescued studies, either by closely overseeing your CRO and implementing study saving processes, or by taking on the study ourselves.

Data Monitoring Committees

Our CEO has lectured on DMCs to the UK Faculty of Pharmaceutical Medicine.  Many studies benefit from a DMC/DSMB and this often helps in Clinical Trial Approval.   We don’t just sit back and let a KOL run the process for us.  We will facilitate the process alongside a clinical chairman.  We have developed a tested rapid feedback system that means decisions can be made quickly, allowing DMC involvement in early phase and adaptive design studies with minimal hold-up whilst awaiting DMC recommendation.


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