The process to select the CRO and/or vendor that is best for you, plus we can do a complete review of their contracts and budgets. We even have templates to simplify your choices.
We introduce you to advocacy groups in advance of your trial starting, help you navigate how to engage, then bring sites into the relationship as soon as possible.
Guidance on electronic tools (Electronic collection of data - eConsent, ePRO, eCOA, eSource, wearables) and decentralized design where applicable.
We will review your schedule of events and help you with the operational design that will be best for patients and your trial.
Bring experience from years of being in front of the global agencies, including the FDA, EMA, TFDA, PMDA, MOH in Israel, Health Canada.
Along the way, we will help with process / learning & cross-functional change management implementation.
We incorporate a global mindset into all design and strategy. With our global experience, we have supported many global clinical trials, from lab to registration.
We bring our own creativity and can-do attitudes to any problems you have for us.
Esther has more than 20 years experience of global research (primarily in oncology, cell & gene therapy & rare diseases), Her expertise is creating an operational design for all phases of the clinical trial.
Tessa has more than 14 years experience in business finance / 10 of these years specifically in global clinical trial research operations. Her expertise is finding innovative operational efficiencies.
Sherry has more than 30 years experience in global research, from monitoring to overall operations. Her expertise is in change management, user adoption, and training/learning strategy and implementation.