About Krystal
Experienced Quality, Regulatory, and Clinical Professional Specializing in Early-Stage Programs
Krystal Santiago is an experienced quality, clinical and regulatory professional with years of successful work in early-stage medical device programs.
Regulatory Strategy Consulting
Exceptional guidance with tangible results. We understand the challenges of compliance and have years of experience developing appropriate and effective strategies to get your medical device to market.
Quality Engineering and Test Strategy
Enhance your QA efficiencies and make your organization development ready. We offer test strategy, test planning, and test management, designed to highlight abilities and uncover deficiencies. We can help you design your performance test strategy and provide submission ready results.
Clinical Trial Development
Accelerate your work with strategic consulting and clinical development for the medical industry. We provide strategic clinical study planning and consulting, including trial design, protocol management, and regulatory submission for early-stage trials.
Data Management
End to end services offered. Protocol analysis to CRF creation through EDC programming, UAT, in-house data cleaning activities, and data lock. We can provide simple EDC systems all the way through complex systems with cross visit edit checks, and adjudication workflows.
With an MS in applied statistics from California State University — Long Beach, and a BS in Industrial Engineering from California Polytechnic State University, Krystal has nearly two decades of expertise in regulatory strategy, quality engineering, clinical data and biostatistics management. She has a wide breadth of experience with focused expertise in early innovative products.
Already have a project in mind? Contact us about your needs and how we can solve them!
Contact Us!About Chris
Chris Santiago is a software engineer with hands-on functional experience with development, quality assurance, product, and management teams. His long list of proficiencies includes:
Architecture
Let us help you design and architect a solution to fit your data needs!
High throughput/low latency data pipelines
Batch processing for data lake/data wharehouses
Full stack development
Design and Implementation
Already have an architecture in place and need a design or coding resource? We can help!
Frameworks
Spring Framework, Spark, Node, Angular
Big Data
Kafka, Pub/Sub, DataFlow, Apache Beam, Spark, DataBricks, ElasticSearch, Big Query
Gaming and Analytics Platforms
PlayFab, DeltaDNA, Amplitude, Adjust, Swrve, App Annie
Languages
Java, Scala, JavaScript, HTML, CSS, PHP, C, C++
Databases
PostgreSQL, Cassandra, MySQL, Big Query, SQL Server, PL/SQL
Public Clouds
AWS and GCP
Chris has a degree in computer engineering from California State University — Long Beach, and has worked in a wide variety of B2B, B2C, and B2B2C settings. He has focused expertise in big data, data analytics, and data mining from world class gaming platforms.
Contact
Contact Us
Location:
Orange County, CA
Call:
(949) 385-0693