CRO
Gaea is an agile full-service CRO in Phase I – III, IIT and RWE trial services in all of Europe, the Russian Federation and the USA.
We partner in Australia.
We offer providers for all services (EDC, safety, labs, drug supply, etc) and we can also work with the Sponsor’s providers under our project management.
We understand the needs of the patient. We pay patient expenses, and quickly as that matters to patients.
We work in complex indications, oncology, hematology, neurology and critical care and neurology where practical hands-on operational experience is essential.
Trial Enrolment Acceleration
Gaea is a trial enrolment acceleration company, brought in by Sponsors to identify and address the issues blocking enrolment at the slow or inactive sites. Every site has its own concerns and we work with the sites to identify them and define solutions.
Clinical Trial Planning
In a consultant role, for the Sponsor that is not well-resourced in clinical operations, the General Director will help to define the clinical strategy and execute it with Sponsor resources or Sponsor choice of CRO. Most recently: in developing and executing an IIT strategy from zero in ovarian cancer.
clinical
Clinical Services
- 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
- Regulatory
- Contracts
- Study Start-Up
- Eligibility Assessment
- Assent in Incapacitated Patients
- Paediatric Trials
- Patient Recruitment
- Monitoring
- Medical Monitoring
- Investigator Meeting Organisation
- Clinical Reports
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.
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