- The CRO claiming relevant therapeutic experience isn’t useful with a huge CRO as the need is for the actual working team on the trial to have the therapeutic experience.
- The CRO should not bait and switch: change the experienced team out once the project is running for a more junior team.
- The CRO must have strong regulatory compliance in the territories.
- The CRO must focus on delivery on time, but with quality, as errors are costly to correct.
- The sponsor and CRO must have a mutual and clear understanding of what tasks are in the budget as the change order process is time-consuming and can be unsettling.
CRO: agile service provision in these VUCA times ( volatile, uncertain, complex and ambiguous)
What do sponsors usually want
What Gaea is and what Gaea does
- Gaea works in Phase I – III and IST, across all of Europe, and as Gaea Clinical Trial Services, across the Russian Federation.
- Gaea works in hospital-originated interventions: such as oncology and haematology; dermatology; gynaecology; neurology, critical (acute, intensive) care such as in sepsis, ARDS; emergency medicine, and infectious disease such as C. Difficile infections.
- The Gaea experience includes indications with limited populations, or difficult populations such as head and neck cancer and intensive care populations where trials enrol 24/7 and populations that may need social media to identify a trial.
- Gaea stresses the need to have patient eligibility confirmation beyond checking boxes on the CRF.
- Gaea doesn’t have start-up CRAs: the national CRA owns the sites from the start of the process. National CRAs and Trial Managers are experienced in country-specific issues of the indication, in site selection, qualification, submissions, initiation, monitoring and close-out. A typical Gaea CRA is 8-10 + years as CRA. Gaea recognises trials are still run by humans.
- Gaea works with novel investigational products such as oncolytic viruses, monoclonal antibodies, and biosimilar products.
- Gaea doesn’t bait and switch: switching out the team to a junior team: every client matter, and we work to meet each client’s specific needs, and we work hard to be part of the team. The General Director engages in every project, as Gaea manages few at once.
- Gaea works with the sponsor- chosen providers, or we offer the Gaea providers that fit what the trial’s needs, in central labs, data management with IWRS and PRO, imaging, logistics, medical monitoring and out to health technology assessment.
- The company places as much emphasis on effective site feasibility as the sponsor will allow: there will always be surprises but this process is fundamental.
- Gaea aims to parallel task the execution of start-up tasks of regulatory and contracts, as we know that site contracts are often the rate-limiting step.
- Gaea has pan European and Russian Federation regulatory resource in oversight of submissions to CA and EC and in advising the sponsor.
- Gaea has an FDA CFR 21 Part 11 and EMA-compliant Trial Master File, as an e- TMF or paper TMF (UK office).
- The company is quality driven with a full SOPs, full audit history and where Risk Management Planning as critical.
- The General Director is experienced in DSMB/IDMC selection, organization management and reporting of DSMB meetings.