CDS Partners

The TrialKit platform is a cloud-based SaaS offering, meaning the services are handled by each set of users. If you require assistance with accurate, efficient study builds, data management, or other study-related services, our trained, CDS-certified service partners are available to help.

Data/Technology Solutions Partners

nmible

At nmible we build innovative expense reimbursement software applications to provide equitable access to clinical trials. We reduce the financial burden of participation with fast, flexible cross-border expense and stipend payments, while also supporting hospital sites by reducing the administrative toil of expense processing. We are technology and automation-focused, and our integration capabilities can power all research apps and services with global payment infrastructure.

OM1

With specialization in chronic conditions, OM1 is re-imagining real-world data and evidence by developing large electronically-connected networks of clinicians and health data in rheumatology, dermatology, gastroenterology, cardiometabolic, respiratory, mental health, central nervous system, and other specialty areas. Leveraging its extensive clinical networks and an unparalleled technology and artificial intelligence (AI) platform, OM1 offers industry-leading enriched healthcare datasets, research analytics, data modeling, decision support, and retrospective and prospective clinical studies.

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.

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.

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.

Reseller Partners

Kavingali, Corp.

Kavingali, Corp. is a technology company that specializes in cutting edge software for healthcare, clinical research and Federal agencies with real solutions by employing blockchain-type services, micro-services, immutable data blocks, machine learning and robotic process automation software.  

Kavingali offers the Qilri Ecosystem, which has TrialKit at the heart of the operations. Qilri is system designed for gene therapy clinical research. The system offers many automations through robotic process automation (RPA) and interoperability to manage the complex nature of genetic research while also updating and monitoring mass amounts of data points to create a very efficient environment for genetic researchers.

US Veteran Owned

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