- Phase I-III
- Project Management
- Data Management
- CRF Design
- Safety Management
- Central and PK Labs Management
- Drug Safety Monitoring Board ( DSMB| IDMC) Management
- Quality Assurance
- Site Feasibility
- Site Selection
- Study Start-Up
- Eligibility Assessment
- Assent in Incapacitated Patients
- Paediatric Trials
- Patient Recruitment
- Medical Monitoring
- Investigator Meeting Organisation
- Clinical Reports
Full Service, Europe and Russian Federation
Sharing Our Experience
Gaea was established in 1994 as a clinical consultancy committed assist in the development of clinical development plans, and project management within sponsors. Gaea expanded to become a trial enrolment company working at problem sites, that are common in any trial. Gaea is also now a full service CRO in Europe and Russia.
Gaea works with difficult to enrol trials and complex IMP in acute care, intensive care, oncology and neurology. We have worked in hospital-based fungal infections, and C Difficile diarrhoea and would be happy to be involved again in the microbiome. The iconic elephant families depend on the matriarch who shares her long experience for the family group survival. Gaea is Sharing our Experience to help sponsors
Nigel Goodman, Director: work history that led to Gaea
“I worked in pharma commercial for many years, so I experienced at first hand the issues from poor clinical development.”
Roche was risk averse, with a “not my job” silo mentality, with project leaders acting to document delay, not drive 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.
In my last four years in Roche in the early 90’s, I was given Board approval to follow my idea that we can move from the current silo-based drug development to the principles of “Thriving on Chaos” (Tom Peters) through a venture team.
I formed and led the Amgen Roche Venture Team to bring Neupogen® (Filgrastim, G-CSF) from end Phase II to European and USA markets, working with Amgen US and the Roche Affiliates.
Amgen US, a new biotech then, chose Roche as a partner for Filgrastim in EU and others. The Roche Pharma Board knew the existing Roche approach would fail; hence the venture team 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 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 GM-CSF, and through national regulatory with 80 national launches by year four. In these years we had two competitors: GM-CSF and those in Basel HQ trying to kill all change.
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, failure was easy.
We had to set the 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 Affiliates to hire specialised resources – and the Venture Team core was never more than 15 people.
So, what has changed?
We live in even more VUCA ( volatile, uncertain, complex and ambiguous)times
But despite outsourcing, and with multiple web-based applications and companies selling “enrolment”, many trials enrol slowly.
Despite the fashion of patient centricity, many protocols are very complex and exclusive.
Sharing our Experience
With my working life in the healthcare 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 and giving all to a Big CRO makes life easier in selection. Size is necessary if its Phase III trial in 2,000 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 over a well – selected small CRO. There is always the risk of Big CRO move of the A -team the sponsor started with to more lucrative projects and switch in the C -team, backed by contracts that are light on delivery penalties and long on escape clauses. The longer the trial takes the more it costs, and someone has to pay for the hours – if not in the bid, and not in the risk-based monitoring, finally in change orders where Big CRO have the financial and legal muscle to delay additional work, if the orders are not signed.”
It’s an environment of rapidly increasing clinical trials: ClinTrials records 262,000 trials open by December 2017.
Despite only nine CROs running ~60% of all outsourced clinical research, there isn’t an obvious increasing efficiency in the development process. In a JCO article by a 26 – year old resident doctor at the end of life care of a 21- year old lady, he quoted Haas The Servant Song, and this struck a chord that it’s easy to forget why we are working in clinical trials: human beings need to care for one another
We are pilgrims on a journey,
We are brothers on the road
We are here to help each other
Walk the mile and bear the load
Gaea and Conservation
In Kenya, we are committed to assisting with the conservation of elephants, other wildlife, moving agriculture towards sustainable permaculture and not slash and burn, and the replanting of trees I oppose hunting.
Gaea and Sustainability
Gaea has the ethos of Refuse – Reduce – Reuse – Repair – Recycle. Located on a 4-hectare hill farm in Macclesfield, UK, where the land that had been denuded by years of subsistence sheep farming is being converted into a nature reserve and food-producing forest garden with vegan no-dig agriculture