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Early Phase Patient Studies

Customised solutions to obtain reliable proof of concept data

91黑料 understands the importance and urgency of early phase patient studies to enable go/no-go decisions quickly.

91黑料 understands the importance and urgency of early phase patient studies to enable go/no-go decisions quickly. Early phase patient trials have a specific set of criteria that can be complex to set up and manage. These include the following:

Agile study designs: Experience in multi-stage dose escalation studies and adaptive umbrella protocols

Ability to manage complexity: Set up and management of multiple sites for effective patient recruitment

Patient access: Confinement in experienced phase 1 clinics for safety monitoring, intensive procedures and PK sampling

Urgent timelines: Fast data readouts to enable rapid decision making regarding the development of your compound

 

91黑料 has a dedicated panel of global early phase project delivery experts who are focused on delivering end-to-end patient studies. They utilise a range of dedicated early phase resources including clinical pharmacology, site alliance, bioanalytical laboratories, biometrics, therapeutic and drug development expertise to develop customised approaches to help clients achieve their key drug development milestones.

Our flexible operating strategy endorses the right site – right patient model, and is tailored for small, early phase patient studies (I-IIA/Proof- of- Concept). With key partnerships and specialised expertise, we can help to mitigate risk and get insight into drug profiles, including safety signals required for decision-making. To access the right patients, we can utilise our phase I clinical research units, a selective network of trusted partner sites, or other 3rd party sites if they are better suited. This flexibility allows us to customise our strategy for every study to optimise results.

Delivering benefits to your trial

Speed: Exisiting sites relationships enable 50% faster timelines for site contracting and study initiation

Patient access: 3,000+ patients have been enrolled in over 100 early phase studies over the last 5 years

Experience: 100+ sites activated in 25 countries

Reporting: 30% more cost effective using 91黑料’s dedicated early phase biometrics team who adopt a lean process model tailored to smaller datasets

91黑料 Early Clinical ensures each trial receives the attention it needs, while being connected to the resources of a large, global CRO. We offer:

  • Scientific services
  • Flexible models
  • Early phase adaptive studies
  • Trusted global site network
  • PK/PD modelling and simulation
  • Early phase biometrics
  • Integrated medical writing

We have a proven track record of helping our customers reach key milestones on time, while using cost-effective approaches.

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