Clinical Operations in Oncology Trials Southern California 2020

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/

Precision for Medicine

Company Description: Precision is the first global precision medicine full service clinical research organization, purpose-built to improve the clinical research and development process for new therapeutics.  Our novel approach integrates clinical operations excellence, along with laboratory expertise, and advanced data sciences to inform every step. This maximizes our clients’ insight into patient biology, delivering more predictable trial outcomes and accelerating clinical development. We apply our expertise to trials at all stages—from early development through approval—with imbedded experience in oncology and rare disease. With over 2000 people and 35 offices worldwide, we stand ready to help accelerate life-changing treatments anywhere around the globe.

Company Website: http://www.precisionmedicinegrp.com/pfmord

Scimega Oncology

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/

eClinical Solutions

Company Description: eClinical Solutions is a leading global provider of cloud based enterprise software and software-driven clinical data services. The elluminate® Clinical Data Hub provides life sciences companies with greater control of their clinical trial data within one platform for all data sources, from aggregation through to standardization, visualization and preparation for submission. elluminate software and data driven services have been used by more than 100 life sciences companies on over 500 clinical trials to reduce cycle time and improve data quality. For more information, visit www.eclinicalsol.com, or contact us at info@clinicalsol.com.

Company Website: www.eclinicalsol.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/

ClinDatrix

Company Description: ClinDatrix, Inc., a CRO, helps pharmaceutical, biotechnology and medical device innovators with clinical projects ranging from Phase I studies to multinational pivotal Phase III trials and post-marketing studies. Our high-caliber project management, clinical monitoring, medical safety, data management, biostatistics, regulatory affairs and quality assurance capabilities make us a valued partner.

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

Globyz Biopharma Services

Company Description: Globyz BioPharma Services specializes in sourcing and supplying clinical trial comparator drugs and ancillaries.Based on years of experience, we possess strong expertise in managing the regulatory & supply chain challenges of sourcing, storing, and distributing pharmaceuticals for clinical trials worldwide. We offer Drug Sourcing, Clinical Packaging, Labelling, GMP Storage & Temperature Controlled Logistics.With GMP compliant global depots, we provide comprehensive solutions & complete global support for your clinical trial material sourcing & supply strategy.

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

IDDI

Company Description: IDDI optimizes the clinical development of drugs, biomarkers and IVD using a unique combination of advanced biostatistics and innovative data collection technology. IDDI covers the full spectrum of trial design, clinical data collection, management, analysis and reporting for Phase I- IV clinical trials. - IDDI’s services include: Clinical Development Plans, Protocol Development, Randomization (IWRS/IRT) with Drug Supply Management, EDC, Medical Coding, Data Management, Biostatistics, IDMC Support, Biomarker/Diagnostics Validation, Medical Writing. - IDDI’s therapeutic areas of expertise include oncology, ophthalmology, infectious diseases and cardiology. - Experience: 27+ years - 980+ trials (630+ in oncology) - 20 FDA/EMA approvals to-date - HQ in Belgium with offices in the USA ( Raleigh, NC, Boston, MA and San Francisco, CA).

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

Myonex

Company Description: Myonex is a global leader in sourcing, distribution, and management of commercial drugs and ancillary supplies for clinical trials and biosimilar research. Our expertise and obsession with ensuring efficient and effective trials are why pharmaceutical and biotech companies, CROs, and clinical packagers worldwide rely on Myonex for their supply needs.

Company Website: http://www.myoderm.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

Stiris Research

Company Description:

Stiris Research is an elite CRO focused on meeting client needs by providing highly experienced Project Management and Monitoring professionals for Phase I-IV clinical trials.  Our strength is seamlessly integrating as an extension of your organization to assemble the perfect team and deliver a highly efficient, cost effective outsourcing solution.

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