CDS Partners
Data/Technology Solutions Partners
OM1
Enterprise Partners
Verily Life Sciences
Launched in 2015, Verily is a subsidiary of Alphabet focused on life sciences and healthcare. Our mission is to make the world’s health data useful so that people enjoy healthier lives. Verily develops tools and devices to collect, organize and activate health data, and creates
interventions to prevent and manage disease. We partner with leading life sciences, medical device and government organizations, using deep hardware, software, scientific, and healthcare expertise to enable faster development, meaningful advances, and deployment at scale.
Full Service Partners
Algorics, Inc.
Founded in 2013, Algorics is a specialized data sciences partner to the life sciences industry focusing on data management, biostatistics, programming, and data standardization. The company supports a global portfolio of biopharmaceutical and CRO clients with cost-effective and high-quality analytical services underpinned by technology know-how and access to high-quality talent across the US, Europe and Asia. We help our customers increase productivity and accelerate development with our technology-backed solutions to enable data standardization and faster statistical reporting.
- Global Clinical and Biometrics Resourcing Solutions include:
- FSP services
- CRO oversight
- Team augmentation
- Study rescue teams
- Project teams
- Clinical Development Solutions include:
- Regulatory, medical and safety
- Clinical operations
- Biometrics
- Oncology innovation
Catalyst Clinical Research
Catalyst is a clinical development organization providing highly customizable clinical research solutions to the global biopharmaceutical industry. Catalyst’s service model is built from more than two decades of listening to customers, devising customer-centric solutions and helping them drive breakthrough clinical development studies leveraging Catalyst’s expert teams and innovative technologies.
- Global Clinical and Biometrics Resourcing Solutions include:
- FSP services
- CRO oversight
- Team augmentation
- Study rescue teams
- Project teams
- Clinical Development Solutions include:
- Regulatory, medical and safety
- Clinical operations
- Biometrics
- Oncology innovation
Nerrele Life Sciences
Nerrele Life Sciences is a multi-disciplined technical organization founded in 2020 by veterans of the clinical research industry. Nerrele specializes in clinical support services with a focus on commercial, academia and government research programs. Nerrele’s team is experienced with solving complex program issues and rehabilitating troubled studies. Additionally, Nerrele can fulfil Small Business Set Aside prerequisites for CROs that are looking to meet federal program qualification requirements.
- Data Management
- Biostatistics
- Personnel management
- Clinical Coding
- Data collection, data warehousing and analytics
- Data base builds and validations
- Clinical data governance
- Process management and regulatory compliance
- Auditing, training, and policy development
- Information Technology support, governance and more
Triall
Triall brings Web3 to medical research by creating a digital ecosystem of blockchain-integrated software solutions that secure and streamline clinical trials. Triall’s solutions make clinical trials tamper-resistant and enable secure and efficient integrations between the many isolated systems and parties involved in clinical trial processes. Triall’s software is co-created with clinical trial professionals to ensure optimal user experience, solving actual industry pain points.
- Data Management
Functional Service Partners
AlvaMed
AlvaMed is a medical device consulting and outsourcing organization comprised of quality, clinical and regulatory professionals with a broad range of complementary skills. AlvaMed strives to build long term relationships with their clients by listening to them and then providing “right sized” services and solutions. AlvaMed has worked with small start-ups to the largest life science companies with over 95% repeat clients.
- Strategic and technical consulting services:
- Outsourced quality, regulatory and clinical support
- Multi-site QMS harmonization
- Quality Management System development and remediation
- Technical Documentation and Risk Management File development
- Internal and supplier auditing (CFR 13485 and MDSAP)
- Q-sub, 510(k), De Novo, IDE, PMA, EU MDR, Clinical Evaluation Report
- Clinical trial design and execution
Fuel Studios, Inc.
Fuel Studios is a team of consultants that provide data solutions fueling new innovations in the medical industry. Fuel Studios bridges the gap between research groups and software providers, working with all aspects of your database: development, modifications, maintenance, validations, reports, and training.
- Advanced reporting
- App integration
- Database build
- Database modifications
- Mobile deployment
- Mobile rendering
SISCAPA Assay Technologies, Inc
SAT develops custom SISCAPA assays for difficult-to-measure protein biomarkers, targets and therapeutics, working with pharma, biotech and CRO partners to enable more reliable development of new treatments and diagnostics. In parallel, SAT is completing a menu of established blood protein biomarker tests encompassing the full range of diagnostic proteins used in medical practice. These tests and panels are used in a variety of sample matrices after tryptic digestion – including serum, plasma, dried blood spots, and various solid tissues.
- Clinical operations
- Study management
Reseller Partners
Kavingali, Corp.
Consulting Partners
Dean Gittleman
Dean Gittleman has 20+ years’ experience in the biopharmaceutical and medical device industry leading biometrics, data management, operations, and clinical information systems organizations. He is an enthusiastic advocate of 21st century clinical development methods, such as eSource (direct data-capture) and risk-based, data-driven, thoughtful monitoring. With a unique hands-on approach, Dean is passionate about driving strategies related to organizational direction, operational excellence, competitiveness, and performance improvement. Dean offers both short and long term consulting engagements for important, interesting, and fun clinical trial challenges, particularly around execution and strategies.
- Specialties:
- 21st-century clinical development
- Pharma/biotech/medical device clinical development
- Clinical information technology
- Strategy development
- Clinical data management, biometrics, and operations
- Leading change and turnarounds
- Building effective teams
Email: dean.gittleman@gmail.com | Phone number: (609) 436-0052
Paradigm Research, LLC
Paradigm Research, LLC was founded by Meredith Mundy in collaboration with an amazing network of clinical research professionals with a single mission: creating a scalable Clinical Research Organization (CRO) to meet the unique needs of start-up medical device and biotech companies. We use our own start-up clinical research experience to understand that start-ups are unique and a cookie-cutter approach to research may not be time or cost effective.
- Clinical operations
- Study management
Delve Health
Delve Health focuses on providing all-inclusive database build and data management packages for Phase I and Post Market studies. Contact jmiller@delvehealth.com for more information.
- Data management
- Study builds
Triangle Biostatistics, LLC
Triangle Biostatistics was founded to provide statistical consulting and statistical programming services to the pharmaceutical industry. Triangle Biostatistics has experience working with large and small contract research organizations and large, mid-size, and small pharmaceutical companies. Contact shale@trianglebiostatistics.com for more information.
- Biostatistics
- Data management
- Statistical programming
- Study build and management consulting
Versagenics
Versagenics has been using its exceptional knowledge of healthcare and clinical research to accelerate our clients’ projects since 2003. Versagenics is a physician-led clinical research organization with extensive experience in database design and development as well as data management and data integration services for the medical device, diagnostic assay, and pharmaceutical industries. Their expert staff is trained to address the varied twists and turns that invariably occur – to provide you with an adaptive, interactive experience. They are adept at designing services to integrate your team’s requirements and provide a seamless solution for your organization.
- Data management
- Medical writing
Database Engineer
john.r.haigh@gmail.com
(310) 384-5950
Clinical Research Database Developer
richardurra01@gmail.com
(773) 319-6041
Contract Clinical Database Developer
tcolbeth@comcast.net
(612) 251-6789
