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Move Faster and Smarter With a
High Impact, Curated ClinOps Team

Emerging biotechs, and other clinical development startups, face many challenges when growing from a small group of smart people with some great ideas to an organisation with proven assets ready for late stage development and/or sale. Just one of these is jumping the gap to become an organisation capable of managing the outsourcing burden of clinical trials to leading CROs and suppliers.

Our team of Curated Clinical Operations leaders can help you bridge that gap allowing you to continue to proceed quickly while also better fulfilling and documenting your Oversight obligations and managing processes, suppliers and tools.

Bridge The Gap Between Investment and Development

Clinical Works helps new bio-pharm ventures and start-ups be clinical research ready faster and more efficiently.

  • Rely on rapid-start, right-sized clinical operations technology and ClinOps consulting services optimized for new ventures.
  • Learn to better manage the outsourcing burden of clinical trials to leading CROs and suppliers.
  • Without burdening C-level leadership, attend to the detail of every sourcing decision; every RFP and every bid defense.

Work With The Experts To Move Your Organisation Forward

Our Clinical Works team is made up of highly experienced Clinical Development leaders and hands-on, operational resources who will complement your existing expertise and team. Our skillset includes:

  • All aspects of Clinical Operations
  • Allows you to manage a wide ranging array of specialised services each of which requires discrete attention and oversight.
  • Procurement and sourcing expertise, including a panel of trusted suppliers
  • IT expertise to allow you to start small with email and some file storage and scale up the technology smoothly to handle large, multi-center trials

Rely on the Leading Clinical Oversight Platform

myClin is our Clinical Oversight Platform, offering a transformative collaboration channel and the most documented, data-driven clinical trial oversight. Think of an extremely easy to use communications layer that is partly a portal (but without the painful bits), partly email (but without the uncontrollable filing sprawl and insecure aspects) while also being a funnel into the TMF for critical evidence of good study management from all study sites and suppliers and dare we suggest once again, proven Oversight!

  • Automatically documenting study oversight activity – particularly when outsourcing services
  • Higher site engagement
  • Improved collaboration between study stakeholders
  • Document control, LMS, study portal, CTMS, eTMF and eISF capabilities
  • Fulfilling sponsor and CRO compliance obligations

What is the difference between Clinical Works and a CRO?

Your investors and senior leadership may think these challenges can be simply addressed by engaging a CRO. While CROs bring invaluable expertise and essential capabilities, they also necessitate compromise in some areas and are unable to provide assistance in your ‘internal processes and systems’ – the gap referred to above. CROs usually assume these internal sponsor mechanisms are already in place – and when they are not CROs are unable by definition to directly help. This often brings opacity and loss of control for the sponsor team that is paying the bill and accountable for the outcome. Then there are issues of Information Technology choices? It is rare for emerging ventures to have the gamut of IT expertise necessary to fully evaluate and select the rapidly evolving technical service offerings, and to understand how to scale operations from pre-clinical through to Ph. IIb and beyond.

Do I have to use myClin to work with Clinical Works?

No, but where the myClin Clinical Oversight Platform helps address these challenges is by bringing a unique combination of people and a software platform to bear. We can augment (or provide) your internal clinical expertise and clinical operations infrastructure needs from early through to late phase development.

Deployed in combination this expert solution helps you get safely between now and some exciting trial results, without the need to make huge eClinical capital investments in infrastructure that you won’t fully use or commit to ill-fitting supplier partnerships designed for mature-enterprise customers that are the bread and butter of the established eClinical players and CROs.

What does a typical engagement look like?

Scenario 1

  • Start-up has 3 C-level staff including CMO. Outline protocols are drafted.
  • Protocols need to be finalised with expert input from KOLs and potential CROs/suppliers.

Scenario 2

  • Start-up has completed some Ph I work and now needs move to multi-centre Ph I/II studies.
  • Need to select CROs and other suppliers while maintaining appropriate sponsor touch of study oversight.
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What can clinical works do for your business?

ARRANGE A CONSULTATION

Clinical Works US

399 Market Street
Suite 360
Philadelphia PA 19106
United States of America

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