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What do sponsors usually want

What do sponsors usually want

  • 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.

About GaeaOÜ

  • Gaea is an agile CRO working in Phases  I – III, IST and observational trials.
  • We recognise that trials are run by busy site staff, now also working with the complexities of remote management so each Gaea CRA has a partner in-house CRA to be an effective team working with sites.
  • Our experience is all of Europe, Ukraine and Georgia and with partners in USA and South Korea.
  • Gaea expertise is in hospital-originated interventions: oncology and haematology, gynaecology, neurology, dermatology, critical (acute, intensive) care such as in sepsis, ARDS and emergency medicine.
  • We usually work with limited populations, or rare  or difficult oncology populations and intensive care populations where trials may enrol “24/7”
  • Gaea is experienced with drugs of immune-oncology.
  • Gaea doesn’t have start-up CRAs: the CRA/ In-house CRA manage sites from the start of the process.
  • Gaea Clinical Operations is experienced in country-specific issues of the indication, in site selection, qualification, submissions, initiation, monitoring and close-out.
  • Gaea doesn’t “bait and switch”: switching out the initial project team to a more junior team: every client matters, and we work to meet each client’s specific needs, and we work hard to be part of the client team. The CEO is engaged in every project, as Gaea manages few at once.
  • Gaea works with the sponsor- chosen ( vendor)s providers,  and we offer the Gaea providers that fit what the trial’s needs, in central labs, data management with IWRS and PRO, imaging,  drug logistics, medical monitoring etc.
  • All  providers work under the management umbrella of the  Gaea Clinical Project Manager as the contact point.
  • Gaea places as much emphasis on effective site feasibility as the sponsor will allow: there will always be surprises, but this process is fundamental to success.
  • Gaea has a strong contracts and budget team  and we aim to parallel the execution of start-up tasks of regulatory and contracts, as we know that site contracts are often the rate-limiting step.
  • Gaea urges that sponsors agree to robust patient eligibility confirmation:  it needs much more than the site checking boxes on the CRF.
  • The CEO is also  experienced in DSMB/IDMC selection, organization management and reporting of DSMB meetings.
  • Gaea is quality-driven and as part of that uses industry gold-standard Veeva Vault CTMS and CRF
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