Case Study:Creating an Effective Functional Services Partnership

Posted by Cytel

Jul 16, 2018 2:49:00 AM

In this blog we share a case study of how we established and ramped up a functional service outsourcing partnership for biostatistics, programming and data management.

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Topics: SAS, Statistical Programming, outsourcing


The Importance of Standardization in Clinical Outsourcing

Posted by Cytel

Jun 19, 2018 9:30:00 AM

 

At the recent PCMG conference in Malta, Adrian Otte ( Independent Consultant, formerly VP Global Development Operations at Amgen) presented to delegates the strategic choices open to sponsors when  choosing an outsourcing model and the three fundamental issues in play: standardization, flexibility and cost. In Dr. Otte's view, standardization of systems and processes is key, but is often...

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Topics: clinical trials, Clinical Research Services, Clinical Development Strategy, outsourcing


Creating Efficiencies in the Vendor Qualification Process: A Proposal

Posted by Cytel

Nov 15, 2017 8:46:00 AM

Each year Halloran Consulting Group hosts‘CORE’ (Clinical Operations Retreat for Executives) as a forum for industry executives to discuss pressing challenges in a collaborative environment. This year, our Senior V.P. of Clinical Research Services, Irving Dark, discussed the topic of vendor qualification and posed the question to the group: are there better alternatives to the traditional...

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Topics: Clinical Research Services, Clinical Data, CRO, outsourcing


Case Study: Cross-study Efficiencies in Biometrics Outsourcing

Posted by Cytel

Aug 2, 2017 7:07:00 AM

As a  biometrics -focused CRO, Cytel regularly works across a program of studies, providing data consistency, and helping to minimize the oversight burden for the sponsor. In this case study, we describe our work with a client on two Phase 1 studies, and how we were able to carry a number of important efficiencies from the first study to the second.  

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Topics: biostatistics, Phase 1, outsourcing, Clinical Research Services, Statistical Programming, medical writing, clinical data management, Clinical Data


The Data Management Plan Takes Center Stage- why is it so important?

Posted by Cytel

Mar 15, 2017 8:51:00 AM

 

A precise and thorough approach to planning is key for success in data management.

The Data Management Plan (DMP) is a critical document in any data management project. It outlines all of the data management work to be done, the timelines and milestones to be achieved, as well as the outputs to be produced. The DMP lets all of the stakeholders know what to expect, how to expect it and when...

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Topics: Clinical Data, Data Management, data manager, outsourcing, Clinical Research Services


Outsourcing success for emerging biopharma

Posted by Cytel

Feb 15, 2017 9:33:05 AM

Outsourcing solutions should never be a one size fits all process, and smaller and emerging biopharma companies may  have different priorities and processes when working with external vendors to larger pharmaceutical organizations.

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Topics: Clinical Data, data manager, outsourcing, Biometrics, biostatistics, RFP


Getting the best out of your biometrics RFP

Posted by Cytel

Jun 23, 2016 7:21:06 AM

 

Vendor selection is a critical component of ensuring clinical trial success.  A 2015 report (1)  suggested that clinical outsourcing penetration will reach 72% by 2020- nearly 3 quarters of all clinical trials will be outsourced to professional CROs.  The process of vendor selection and management may be managed by the clinical operations teams within smaller companies, or by outsourcing and...

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Topics: Clinical Research Services, outsourcing, Clinical Development Strategy, EDC, database build


How to Use Outsourcing to Reduce Clinical Development Risk

Posted by Esha Senchaudhuri

May 28, 2015 4:47:00 PM

Risks in drug development range from taking the wrong drugs forward to Phase 3 to investing in a drug development program at a time when regulatory standards are evolving, or competition is catching up with comparable products.

There is a particular source of risk, however, which deserves special attention. Currently, the pharmaceutical and biologics industry outsources approximately $25...

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Topics: Data Management, Clinical Research Services, outsourcing, Clinical Development Strategy


You Own This!

Posted by Laurie Halloran (Guest Blogger)

Oct 7, 2014 2:00:00 PM

Guest blogger Laurie Halloran is the President and CEO of Halloran Consulting Group, a management consulting firm for the life-sciences industry. Here she offers her take on the importance of accountability, obligation and 'ownership' in consulting for pharmaceuticals and medical device companies.

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Topics: Clinical Research Services, Cytel Consulting, outsourcing


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