Clinical Operations in Oncology Trials Handbook 2021

GenomOncology

Company Description: GenomOncology strengthens your precision oncology program by transforming valuable, but unusable data, into actionable oncology treatment options and strategic insights to drive measurable results.

Company Website:

Axiom Real-Time Metrics

Company Description: Axiom delivers intuitive, powerful and cost-effective eClinical solutions and services focused around your entire study. Services include: DM, Biostatistics and Pharmacovigilance. Axiom's eClinical suite, Fusion, delivers a powerful range of innovative end-user focused, unified functionality and 15 modules. Axiom serves as the Connected Hub for your entire clinical study data and operational needs.

Company Website: http://www.axiommetrics.com/

Clario

Company Description: Clario is a global data and technology company that minimizes risk in clinical trials, helping sponsors bring treatments to patients quickly, with confidence. Clario’s solutions have supported half of FDA new product approvals since 2013 by enhancing trial oversight, enabling site optimization, increasing patient engagement, and measuring treatment efficacy while ensuring patient safety.

Company Website: http://www.ert.com/

CE3

Company Description: Ce3 is a full-service CRO with a focus in oncology, providing support and services exclusively to biotech companies. We specialize in early phase development, managing studies from FIH (first in human) to Accelerated Approval.  Having a therapeutic concentration promotes refinement of our expertise, skills and tools throughout the organization. We leverage best practices and sharpen efficiencies across each service area to support our clients in the most cost-effective manner.  We deliver quality data faster, easier and better to facilitate timely decision making. Our team is energized by the complexities and challenges of the everchanging landscape that defines oncology research.  Our name, Ce3, represents our core values and serves as the foundation of our operations: a collaborative approach in managing studies with experience, efficiency and excellence!

Company Website: http://www.ce3inc.com/

Medidata

Company Description: Medidata is leading the digital transformation of life science, with the world's most used platform for clinical development, commercial, and real-world data. Powered by artificial intelligence and delivered by top-ranked industry experts, Medidata helps pharmaceutical, biotech, medical device companies, and academic researchers accelerate value, minimize risk and optimize outcomes. Medidata and its companies, Acorn AI and SHYFT, serve 1,300 customers and partners worldwide and empower more than 150,000 certified users every day to create hope for millions of patients. Discover the future of life science: www.medidata.com

Company Website: www.medidata.com

TrialCard

Company Description: TrialCard provides solutions for Patient Access, Prescription Abandonment, Hub/Reimbursement, Analytics, and Clinical Trial Support.

Company Website: http://corp.trialcard.com/

Scimega Research

Company Description: Founded in 1997, Scimega Research is a Canadian-based oncology clinical research organization (CRO) with a defined mission to attract cutting-edge oncology trials to Canada. We play a vital role in connecting sponsors developing novel cancer compounds with a network of highly motivated principal investigators and their patients.

Company Website: http://www.reversefeasibility.com/

Signant Health

Company Description: Signant Health provides solutions that simplify every step of the patient journey to make it easier for people to participate in, and for sites and study teams to run, clinical trials. Signant unites eCOA, eConsent, Patient Engagement, IRT, Clinical Supplies and Endpoint Quality into the industry’s most comprehensive patient-centric suite – an evolution built on more than 20 years of proven clinical research technology. Our intense focus on the patient experience, deep therapeutic area expertise and global operational scale enable hundreds of sponsors and CROs (including all Top 20 pharma) to extend the reach of drug development, expand patient opportunities and improve data quality – helping them bring life-changing therapies to our families and communities around the world.

Company Website: www.signanthealth

VOLT

Company Website: http://www.voltinternational.com/pharma-associates

BioTel Research

Company Description: As the research division of BioTelemetry (Nasdaq: BEAT), we provide one of the world’s largest clinical data networks. BioTelemetry Research’s broad range of Cardiac and Imaging services support both safety assessments and efficacy evaluations across all major therapeutic areas, through all phases of clinical trials, in every global region.

Company Website: www.gobio.com/clinical-research/

Pratia

Company Description: Pratia is a Research Site Network with 90+ centers across 6 countries in Europe. With 700+ researches carried out since 2012, Pratia brings tech-savvy, adaptable solutions in innovative treatments at the convenience of Patients & Professionals. It is a platform for innovative medicine, which offers the best mix of sites, expertise, access to Patients to each protocol, as well as close collaboration with the local healthcare systems. Pratia can address the dynamically changing requirements in the industry, including remote monitoring and decentralized studies. In 2014 Pratia joined Neuca Plc. - the leading organization in the pharmaceutical wholesaling and the healthcare industry. 

Company Website: https://pratia.com/

DSG

Company Description: DSG, Inc. celebrates over 25 years as a leading global eClinical provider with a fully integrated suite of innovative technology solutions and data management services: Award-winning eCaseLink™ EDC & DSG Designer for Enterprise licensing with CDISC standards; Risk-Based Monitoring, eSource, IWRS Randomization and Clinical Supply, Drug Safety, Patient Profiles, ePRO, CTMS, Site Payment, Protocol Violations, ad-hoc reporting, CDM services, and digital on-demand Clinical Printing services.

Company Website: http://www.dsg-us.com/

EPM

Company Website: http://www.epmscientific.com/

Medrio

Company Description: Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, and ePRO solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations. www.medrio.com

Company Website: www.medrio.com