How to prevent clinical trial protocol deviations

When protocols are not followed, it can create serious issues that slow the study down or significantly increase costs.  These best practices can help sponsors and CROs work together seamlessly to prevent and alleviate protocol deviations in their clinical studies keeping development on time and within budget.

The life of a virtual clinical trial participant

I am currently participating in a clinical trial. I have neither seen a physician nor traveled to a site for a procedure. During my first 15 days of trial participation, my samples have been sent 43 times - and I never once had to leave my house for it.

Q&A: 2018 trends with Pharma IQ

Predictive analytics will help keep clinical trials in the world of actual data rather than succumbing to “alternative data.”  No longer will we be stuck estimating enrollment rates, trial costs or other simple outputs of multi-factorial processes.  

Positioning for the future of clinical research with technology

Biotech companies are being approached with technological advancements that can make drastic improvements in efficiency, speed, and accuracy of clinical trials. But experts see a disconnect between the future of clinical trials and the technology being adopted to support them.

7 trends in clinical trial data

Clinical trials are incorporating data from so many more sources today: genomic sequencing, medical imaging data, lab data, wearable sensor and other mHealth data. Today’s clinical research requires a technology platform that can ingest and integrate data from any data source.

Med device breakfast: Designing & implementing effective clinical trials

Running efficient and effective clinical trials for medical device and diagnostic companies has become increasingly complex. The sheer volume of available genetic and epigenetic data on patients, outcomes data on different procedures and treatments, and the variety of data from personal health trackers can be overwhelming. 

Three questions on indication assessment

Indication assessment ensures a clear understanding of unmet medical needs, patient segmentation, and what the therapeutic profile—efficacy, safety, dosing, etc.—needs to look like to meet those needs.

How to get the most out of a CRO’s bid defense

Bid defenses can, when executed properly, be extremely valuable. We have some insights to share that we have learned from sitting through years of CRO bid defenses and seeing both the relationships and the conduct of the clinical study play out afterward.

3 Protocol Design Strategies to Enhance Patient Recruitment

How many of the clinical trials that your company has conducted have met the initial patient recruitment timelines? How often have you seen recruitment issues increase costs or cause delays in your company’s operational objectives? Nearly 80 percent of clinical trials experience delays or even early termination due to recruitment issues.

Measuring the Health of CRO-Sponsor Relationships

As the majority of clinical trials involve external collaborations, healthy vendor relationships cannot be overemphasized. In parallel, the market for CROs (contract research organizations) continue to consolidate, and these businesses become as large or larger than the companies they serve.
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