Remember when
trainings for clinical teams guaranteed a mostly clean clinical trial?
Company
Founded in 2014, Psynthesys is a San Francisco based biopharmaceutical technology company developing tools to optimize performance of clinical teams by making real-life workplace situations powerful learning experiences. Our workflow learning platform, In Situ, added to the day to day workflow of clinical teams, ensures that individual clinical team member knowledge stays fresh and on point. Integration with existing Electronic Data Collection platforms creates a dynamic knowledge building combination that answers a sponsor company's need to maintain the highest level of information integrity.
Background
In 2007 after 8 years as a commercial illustrator and graphic designer, Psynthesys founder Rick Erickson, turned his attention to the world of life science innovation. He embarked on a journey ultimately leading to team trainings for clinical trials, managing, producing and designing all educational program facets from training strategy to curriculum for phase 1-3 clinical trials. Then, a big question began to brew.
Sticky Information
In particular, Rick's work with a mid-size biopharma concern became a pet project. Having partnered with the company's clinical operations team to successfully bring a novel antibiotic to US, European and South American markets, 6 new Phase 3 trials to re-indicate the antibiotic for pediatrics began. Rick was tasked with leading a push for innovative training solutions that in the words the VP of Clin ops "made protocol information sticky." The context for this sticky information focus was expressed as lack of training expense R.O.I. – i.e., for all the expense of training, the instance and costs of protocol deviations and compliance issues failed to fall. Was there something that could be done to help learners retain what they were taught sufficiently to impact their performance?
Context & Learning
Experiments began. We educated ourselves on the a, b, c's, of cognition and learning, using what we learned as a baseline to brainstorm on applying to clinical trial situations. The big challenge to ensure the science was understood and that conditions under which the science worked were relevant and specifically applicable to the trifecta investigative roles of the scientist, patient caregiver and researcher. We all agreed that by locating learning matter nearest the contexts of clinical trial scenarios, memory had a higher probability of readily activating when exposed to experiences corresponding with learned matter in the field. We organized information the way it would most often be experienced by learners and staged subject care simulations to mimic such encounters. Using decision and problem solving discussions in a live forum to engage learners, a blend of lively classroom, social/collaborative learning became the centerpiece of our trainings. The big step of creating an even more powerful way to correlate investigator experiences with learning was soon to come. You can learn of it on this site - In Situ; a multi-device learning experience platform that changes clinical teams learning to learning with measurable R.O.I. outcomes
Our Mission, Our Mantra
Catch mistakes before they happen!
Too simple right? Or is it? Being aware of the mass of moving parts and the mountain of crazy making detail associated with clinical operations, we asked, "what could possibly go wrong?" The answers we've gotten come from any number of sleep deprived project managers propped up by caffeine and sheer will power. Truth is, no way can the average clinical team professional effectively attend to all of it at once.
BUT – s/he can attend to the most salient information and tasks of most import that have direct impact.
Our technology supports Workflow Learning that creates laser sharp focus while promoting experience-centered learning. Immediate access to the right actionable information equips your clinical team members to verifiably contribute to your study's success.
Experience Where Clinical Trials Happen
Our team is a collective of drug development and biotech innovators whose day to day concerns in the execution of real-life clinical trials. Individually and collectively their impact within clinical research domains has enriched medical science addressing health concerns worldwide.
FOUNDER/CEO, RICK ERICKSON's 12 years of instructional design and educational programming with clinical teams left him with one big question: With the exorbitant resources spent to train clinical teams why are clinical trial errors, omissions and oversights so excessive? Extensive explorations across a variety of commercial industries led to an understanding of the basic disconnect between...
CO-FOUNDER/DIRECTOR OF SOFTWARE ENGINEERING, COLIN MILGATE is the mastermind behind the technical design and development of Psynthesys' information processing architecture. Biopharma companies like Pfizer, Medivation and PDD Trials have relied on Colin's deep expertise to build and maintain computing systems capable of meeting the massive data processing needs of large biopharma...
Advisors
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Robin RobertsAn effective clinical operations leader with over 15 years of pharmaceutical industry experience in R&D, clinical research, clinical process improvement and digital strategy. A successful team leader experienced in driving innovation through disruptive innovation/technology and effective stakeholder management. A proven assessor of current and emerging technologies with a pending US patent and established communication skills. Experienced performing industry-wide landscape analysis of current and emerging technologies and guiding those innovations through project implementation. Demonstrated success partnering with key stakeholders and presenting business critical information at senior levels. Comprehensive experience in protocol development/implementation, trial management according to GCP, ICH and FDA guidelines and extensive knowledge of the end-to-end clinical operations process.
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David MaltzDAVID MALTZ is the Founder and Managing Partner of Intervalent, an independent advisory and consulting firm in San Francisco, CA that specializes in product development and innovation strategy for consumer-facing medtech and digital health companies with over 20 years in life sciences product design & development. David is a design thinker, innovation catalyst, and product realization expert with "T-shaped" skillset, combining deep product design and development experience with broad business and management aptitude. He is passionate about developing sophisticated technologies into human-centric products. David's startup work includes Multisensor Diagnostics (chronic disease management via rapid medical assessment) and Circadia Technology (sleep tracking and light therapy). Service provider clients include WaveEdge Capital (healthcare investment bank), iO Life Science (medical device design and product development consulting), and Tietronix Software (medical device software & apps). In David's combined 12 years at Nektar Therapeutics and Novartis Pharmaceuticals Corporation, he oversaw the design, development, and manufacturing of several novel pulmonary drug delivery systems. Before Nektar, David held technical and leadership positions at Game Ready, a startup in the orthopedics space, and Bridge Design, an industrial design and product development consulting firm. ​ At Novartis, David was also deeply involved in efforts to leverage information technology to improve both clinical study operations (Trials of the Future) and patient outcomes (Digital Medicines), and oversaw the development of all Mobile Medical Apps within Novartis that are regulated as medical devices. He continues to be interested in the harmonious integration of medical devices and information technology, including digital biomarkers. ​ David holds BSE, MSE, and MBA degrees from Stanford University, has numerous patents pending and awarded, and is an author of several publications in both inhaled drug delivery and the medical device development process.
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Luis GutteriezLuis is a business leader with a passion for helping companies bring new medical technologies to market, and then make the transition to becoming successful commercial enterprises. He has a strong track record of driving revenue and profit growth in the organizations and has led, largely by developing propagating innovative service offerings to the life science companies we have served. My key strengths include: crafting commercialization strategies for new drugs and medical products; leading sales, marketing, and customer service functions; increasing operational efficiency and quality of service delivery; leading, aligning, and motivating global teams of 800+ employees; and analyzing financial data to inform business decision-making. Luis provides consulting/advisory services to companies bringing new medical products to market, as well as to service providers and investors that focus on the life sciences space. Luis holds a Bachelor's Degree from Harvard University and an MBA from the Stanford Graduate School of Business.
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