Summary of Services of Gaea | Clinical
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Gaea is a full-service bespoke CRO:
Bespoke means we work to meet each client's specific needs and we don't provide "boilerplate" template solutions.
The Gaea UK office is the core with a team of CPM, CTA, accounting, and IT. QA is based in Russia. As every sponsor's needs are different we offer the vendors that fit for the services that each sponsor needs in data management, safety, PRO, imaging, medical monitoring etc.
Gaea works in phase I- III trials, with hospital- based interventions: for example, oncology, haematology, critical care, and infectious diseases such as CDI.
We work across all of Europe. With the Gaea Branch Office on Moscow we cover the Russian Federation. We partner in the USA and Latin America where we also maintain the role as project pivot and driver.
Our Clinical Operations national team of CRA- CTM has a minimum 8 years' experience- we have no junior CRAs.
Our experience includes indications with limited patient populations or novel ATMP as investigational products: in oncology - this includes oncolytic viruses- Gaea so far is the only CRO that has run a Phase III trial with an IV oncolytic virus. We also work with GMO; we enjoy the complexity of therapeutic vaccines, and with usual monoclonal immunotherapies. With such ATMP the often-neglected pharmacy plays a critical role.
Gaea is a problem solver at clinical sites: usually recruitment, but also patient retention, imaging, quality etc.
At sites with some activity, the CRO CRA often only has time and experience to verify source data: once the site is active we are able to visit to focus on site patient recruitment activities CRO where CRA time on-site is often limited, for example, from the use of risk-adapted monitoring
Unlike consultancies that immediately offer activities such as web sites and leaflets as answers to enrolment, Gaea is practical - sites have been CRO and sponsor selected and worked through regulatory so should have patients. We know CRO feasibility is usually superficial but the first step is to look at the issues at the sites.
We use our senior CTM resources in each country to visit the problem sites and identify the real problems, and report both problems and suggested solutions.
We also want to share best practices from successful sites with poor performing sites
We can also execute any solutions that we suggest, or the problems pass back to the CRO.
We also can work to motivate the site Principal Investigator as the trial 'gate-keeper' at any site.
Gaea conducts in-depth site feasibility:
We can conduct in depth site feasibility as we now that most CRO feasibility is superficial, and the problems start from there.
Gaea offers clinical and pre commercial consulting:
The director has over 35 years in the industry, and is still hands on and strategic and driven to deliver and willing to share this experience. His most recent work is as Clinical Trial Expert on a legal case.
We offer our clinical auditors for site pre regulatory preparation.
My history that led to Gaea:
Nigel Goodman, Director
"I worked in pharma commercial for many years so I experienced at first hand the results from the issues of poor clinical development.
In my last four years in Roche I formed and led an experimental Venture Team to bring Neupogen (Filgrastim, G-CSF) to market.
Roche at the time was risk averse, with "not my job" silo mentality, with project leaders documenting delay not driving progress, so development was both slow and quality deficient. Clinical trials were badly designed and executed, waivers and compassionate use were abundant, trials were slow to be reported, resultant regulatory dossiers were very poor and so products were late to market and then did not meet market needs. Affiliates were despairing of the HQ output. The result is obvious of declining revenue and the company was slipping down the global rankings.
Amgen chose Roche as partner for Filgrastim. The Board knew the existing Roche approach would fail; hence the venture team I was accepted as an experiment, and reporting to the Board.
In four frantic years, the team worked in a very complex partner - HQ - affiliate relationship, taking Filgrastim from end phase II through two small Phase III trials, through production as the first vial in Roche, through regulatory as one of the first drugs through the centralised EU regulatory process, through pre commercialisation against GMCSF, and through national regulatory with 60 launches by year four. In these years we had two competitors - GMCSF and those in Basel HQ trying to kill change.
But Neupogen changed Roche. Neupogen also changed the delivery of conventional chemotherapy, revolutionised high dose chemotherapy, and made peak sales of $4 billion a year to be a driver of the growth of Amgen.
In the environment we worked in n failure was easy: the team used as our modus operandi the book "Thriving on Chaos" by Tom Peters.
We had to set goal of being first CSF to market that could not be missed, and with the addition of the highest quality at the core of all we did, as to hit the time goal and fail on quality or not meeting market need would be a fail.
We were budget rich and resource poor. We worked as a small cross functional team: everyone who joined made a personal commitment to the team as it was not about our own enrichment - we avoided working in a box called a job description - we worked without a CRO - we used experienced resources we could contract - we pushed the reluctant Roche affiliate to hire specialised resources - and the Venture Team core was never more than 15 people.
Sharing our Experience
With 35 years in the industry, as Gaea Director I want to be an active member of a project, to use my years of experience in clinical to bring trials faster through to completion with quality at the core.
Gaea offers our services in an environment where the Big CROs provide huge size and claims of delivery from multiple offices,
which is often taken as security by sponsors. Size is necessary if its S Phase III trial in 5,000 patients.
Size with Phase I in 30 or Phase II in 100 brings bureaucracy, complexity and results in loss of speed and does not improve quality.
There is always the temptation by the Big CRO to move out the A -team the sponsor started with to more lucrative projects and bring
in the D -team, backed by contracts that are light on delivery penalties and long on escape clauses. The longer it takes the more it
costs and Big CRO need to bill large amounts of services - if not in the bid, and not in the risk based monitoring, finally in
change orders where they have the financial muscle to delay work if the orders are not signed."