Don't Let eCOA or eSource Tank Your Study
Advice on sourcing and implementing
digital outcome technology
in clinical trials
#digital_complexity
Avoid eCOA/eSource 'screw-ups'.
Implement alerts and safeguards and set digital-focused requirements for vendors in RFPs.
Today, digital technology has found its way into clinical trials as eCOA, eSource, sensor data, digital biomarkers.
Digital can drive efficiency, but trial complexity is escalating, and vendor capabilities are changing on a near-monthly basis.
Protocols specify which Clinical Outcomes and Assessments (COAs) to use, but they set no standards or safeguards for the quality of outcome data, digital data collection and overall implementation.
Service providers sell and implement COAs in bulk. Their ideal implementation is often ‘cookie cutter’.
Ask yourself:
- Do we spend too much time managing vendors?
- Is our study team constantly putting out fires?
- What keeps us from working more with PIs to ensure quality data and enrollment?
Alerts and safeguards
allow the study team to navigate the constantly changing technology and clinical trial practices and make
all necessary decisions upfront.
#get_advice
Get precise information to protect your study.
Be informed by sharpening your RFP requirements specific for eCOA/eSource and source meaningful vendor proposals.
Leverage our expertise in asking vendors the right questions with the right degree of specificity.
Use our experience with critical clinical and operational “e” risk factors that you must have in your RFP specs.
Don’t settle on cookie-cutter solutions. Assess true value.
The same bid from different service providers can mean very different things.
Analyze bids, decipher vendor lingo, check service comprehensiveness, and assess the true added value of technology.
Get advice on identifying areas of misalignment between bids and RFP specs, and uncover operational challenges for deliverables.
Maximize vendor value and cost control.
Same bid, different vendors, different budget line items, different costs.
Break down complex grids and map line items to your specs.
Use our experience in identifying risks of overspending caused by change orders, and operational delays.
RFI Support.
Look beyond the usual suspects, the last service provider is not necessarily the best fit for your next study, preferred status or not. The industry changes at digital speed. We follow it.
Bid-Defense Support.
Use our experience from hundreds of bid-defense meetings. Bring clarity to vendor options with rigorous preparation and asking the right questions to avoid dog and pony shows.
#sponsor_value
Program Management& Operations
Study start-up with less pain, fewer surprises, fewer band-aids.
Clear timelines and risk mitigation from all vendors involved in eCOA/eSource and related digital integrations.
Alignment of COA milestones across vendors.
Precise and detailed work orders based on best-practices for eCOA/eSource implementations.
Procurement
Faster bid-to-contract process and evaluation; no struggle with vendor lingo.
Tighter budget control, and clarity on budget line items.
Risk mitigation on change orders.
Clinical Science
Clear representation of COA-specific risk factors affecting implementation quality in service provider RFPs.
Improved control over site burden and protocol acceptance.
#my_story
I have accumulated a unique perspective on eCOA/eSource implementation in my work since 2009 helping CNS sponsors in translating protocols into clinical outcome implementations and digital technology. I have overseen the building of hundreds of proposals (‘bids’) and work orders for sponsors and played a key role in the transition from paper to digital and eCOA /eSource in clinical research studies. I have seen the results of many digital and eCOA implementations in studies.
In this work I have collaborated closely with clinical scientists, operations specialists, data managers, regulatory and recruitment experts, procurement and vendor management and consultants, and I have been in dialogue with CROs, sites, IT providers, copyright holders and scale authors and other industry leaders.
Prior to my involvement with clinical outcomes, I worked on e-procurement enterprise technology for pharmaceutical companies as well as high-throughput screening and sample management and computational chemistry solutions. My PhD is in quantum chemistry from the University of Technology in Vienna.
#expert_testimonials
I have worked with Peter on a number of opportunities in the last 10 years, all related to the provision of rater training services. Peter has obvious expertise in the area of clinical outcome implementation, especially with regard the crucial issue of quality control, a critical aspect of successful trial delivery in the CNS field. He has extensive experience or clinical trial methodology and a deep understanding of the commercial and operational aspects of clinical outcome assessment. In all our dealings he has been refreshingly straightforward. In part this has been due to his business-like demeanour, but also to the depth of his knowledge about what it takes to get things done. I’ve always enjoyed working with Peter and I am delighted to have the opportunity to endorse such as hard-working, reliable and knowledgeable individual.
John Harrison, PhD
Principal Consultant at Metis Cognition Ltd
Peter has been instrumental in getting Medavante at the forefront of AD related research, notably clinical trials. He has expertise in clinical outcomes, particularly outcome implementations as well as in quality control trial methodology. He has vast CNS industry expertise that he is willing to share with everyone he works with. He is a pleasure to work with, reliable, trustworthy and always good humoured.
Prof. Philip Scheltens, MD
VU Amsterdam
Great people are not easy to find. Much less so, talented and knowledgeable people who effectively combine business with science and apply it to innovative product development for commercial clinical research.
I collaborated with Peter and his colleagues on several challenging eCOA-related initiatives in psychiatry and neurology. Peter effortlessly connects knowledge gaps among scientists, marketing and sales teams, and software developers with a can-do mindset, straight-forward openness, flexibility, and creative problem solving. His leadership style forged unified collegial relationships that resulted in a successful cross-functional team effort that helped the company establish a solid presence in digital clinical outcome assessments and data collection for CNS trials.
I highly recommend Peter as a senior leader within Life Sciences-centered companies that are looking for a strategic thinker with commercial experience, a solid business development track record, and a strong technical knowledge in e-clinical data collection and outcome measurement methodologies.
Monika Vance
Managing Director, Santium
#contact
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