Consider Site Capabilities to Determine Risk-Based Monitoring Strategies

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Clinical site monitoring is a key consideration for life science companies’ clinical trial timelines and budgets.  Regardless of development phase, the level of planned site visitation — which can take up not only a lot of clinical research associates’ time, but also trial budget — can potentially accelerate or delay trial progress.  While in-person site visits help sponsors identify a number of issues, risk-based monitoring strategies can improve monitoring efficiency and save companies time and money. Continue reading


Trial Master File Management: Laying the Groundwork for Clinical Success Starts with Innovative Strategies

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Companies traditionally leverage a master file for each of their clinical trials. These master files help them organize trial documents and, consequently, adhere to regulatory standards.  Generally, Good Clinical Practices (GCP) guides what documents companies elect to include in this file.  Additionally, included documents range from those necessary for trial set-up to documents signifying trial completion. For example, companies would need to include materials as trial protocols, feasibility assessments, patient informed consent documents, to name a few. Continue reading


Risk-Based Monitoring (RBM) Defrays High Monitoring Costs during Longer Clinical Trials

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

For most life sciences companies, on-site monitoring is a significant expense during clinical studies.  In fact, one CRO executive interviewed by CEI’s analysts suggests that monitoring budgets — which supports the number of monitors required for the trial and their travel expenses — can equal up to 60% of overall clinical trial costs.  To defray some of these costs, many pharmaceutical companies are turning to risk-based monitoring (RBM) as an effective cost-reduction technique. Continue reading


Risk-Based Monitoring Strategy: Embrace Centralization Technology to Save Resources During Clinical Trials

Victoria Cavicchi, pharmaceutical clinical trial researcher
By Victoria Cavicchi,
Research Analyst

Risk-based monitoring (RBM) has recently emerged in the pharmaceutical industry as a way to reduce the costs of clinical trials while maintaining, or even improving, site protocol compliance and communication. In traditional trials, sponsors visit clinical sites frequently — often every four to eight weeks. However, these in-person site visits and monitoring strategies account for a large percentage — a suggested 30% — of clinical trial costs.  A risk-based monitoring strategy — especially when combined with in-person visits — conserves time and staffing resources while still enforcing good clinical practices. Continue reading


Clinical Trials Staffing: Recruiting CRAs Best Suited to Trial Needs

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Clinical research associates (CRAs) are a crucial part of a company’s clinical trials staffing. CRAs often work as a liaison between the company and investigator sites, ensuring that the trials run smoothly. As such, CRA responsibilities range from tracking patient consent forms to monitoring patient data and visiting investigator sites. Cutting Edge Information’s recent study on clinical trials finds that when recruiting CRAs, companies consider a number of qualities, including: Continue reading


All Right, Meow: Patient Recruitment for Animal Health Studies is Serious Business

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Team Leader

Patient recruitment isn’t just human subjects. Cutting Edge Information has conducted a number of clinically focused projects, examining an array of industry challenges.  How companies recruit for their clinical trials — including what works and what doesn’t — is a hot topic for clinical stakeholders.  A recent CEI study on patient recruitment highlights the percentage of companies conducting activities and who specifically —trial site, sponsor or CRO — is coordinating these activities. Continue reading



Selecting the Right Vendor for Phase I Clinical Trials: Preferred Provider List or Bidding Process?

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Research Analyst

Phase I clinical trials are supposed to be the quickest, easiest trials with the simplest question in mind: will the drug harm the patient?  No? Good, then you may proceed. However, sometimes the trials are not as straightforward as all that – there can be problems in recruiting, sites can drop out, etc. For many companies, a good way to expedite Phase I trials – and save a little money – is to use contract research organizations (CROs) to administer the trial. In fact, surveyed drug companies outsource 70% of Phase I trial costs. Continue reading


Get Safety Data Right the First Time in Critical Phase 3 Trials

Ryan McGuire, lifecycle management tactics expert
By Ryan McGuire,
Research Analyst

Getting safety data correct the first time is essential to keeping drug development on schedule and avoiding potentially costly overruns.  Several recent cases in which regulators requested additional drug safety data upon review of products new drug applications (NDA) demonstrate just how costly these overruns can be.  Fulfilling these requests can delay final approval for years — costing companies millions for additional studies and hundreds of millions in lost revenues. Phase 3 safety data is a particularly important consideration for preventing these costs. Continue reading


Targeting the Alpha-7-Nicotinic Receptor May Be More Difficult Than Companies Originally Anticipated

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

One of the characteristic symptoms of schizophrenia is patients inability to differentiate among important and unimportant stimuli in their environments.  Researchers attribute this symptom to a “P50 Auditory Gating deficit.”  After individuals hear sounds, their cochleae typically form small electrical voltage potentials (auditory evoked potential) that are transmitted from their cochleae to their cortices.  P50 represents the period from 20–70 milliseconds after patients hear a sound, but before the impulse reaches their cortices, allowing their brains to process it.  When the P50 period becomes disrupted, the amplitude of the auditory message becomes reduced, making it harder for patients to process the now-quieter message. Continue reading