Outsourcing in Clinical Trials West Coast 2021 - A Virtual Conference

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

Novotech

Company Description: Novotech is an Australia based clinical CRO operating across Asia and South Africa. Headquartered in Sydney since 1996, Novotech has come to be recognised as the CRO of choice for many US and European biotechnology firms in the Asia Pacific. Our full service offering includes clinical program management, biometrics services and regulatory affairs.

Company Website: http://www.novotech-cro.com/

Saama Technologies

Company Description: Saama Technologies is the advanced clinical data and analytics company, unleashing wisdom from data to deliver better actionable business outcomes for the life sciences industry. Saama’s unified, AI-driven clinical data analytics cloud platform seamlessly integrates, curates, and animates unlimited sources of structured, unstructured, and real-world data to deliver actionable insights across all therapeutic areas. The award-winning platform gives unprecedented real-time visibility into clinical data, enabling sponsors to file New Drug Applications (NDAs) more efficiently to bring drugs to market faster and at lower costs. For more information, visit http://www.saama.com.

Company Website: www.saama.com

Anju Software

Company Description: Anju Software is a leading provider of comprehensive software solutions to the life sciences industry, spanning the spectrum from clinical operations to medical affairs and commercialization.  While traditional technology providers offer platform solutions that force you to adopt their technology their way, the strength of our offering focuses on delivering your platform, your way.  Leveraging the Anju Bus integration technology, Anju will add complementary solutions to your environment and create a tailor-suited platform that perfectly meets your needs. With the Anju PERSONALIZED PLATFORM™, we apply our demonstrated expertise to our pharmaceutical, biotech and CRO clients to help them reduce complexity and risk.

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

Avantor

Company Description: Avantor provide Global Equipment Solutions to the Clinical Trials industry.  Currently  Avantor supports clinical studies running in over 70 countries taking care of all aspects of the medical equipment and related products on your clinical studies from initial enquiry through to end of study removal

Company Website: https://www.avantorsciences.com/en/index.html

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/

CATO SMS

Company Description: CATO SMS experts deliver specialized drug development services and solutions, designing and executing studies in complex indications and modalities. We have the experts to tackle your toughest challenges with confidence and precision. With over 30 years of experience focusing on the needs of small and emerging companies, our team is optimized to deliver for sponsors like you. Our expert teams effectively design and execute studies — from strategy to approval — in complex indications and modalities across a variety of therapeutic areas, with a proven center of excellence in oncology. We provide valuable insight, high-quality deliverables, and unmatched client service, giving you expert guidance to identify the specialized solutions you need, every step of the way.

Company Website: www.cato-sms.com

Cenduit

Company Description: Cenduit has deployed over 1700+ studies, at over 80,000 global sites serving 1M+ patients – supporting virtual, decentralized and site based trials.  Our comprehensive randomization and trial supply management capabilities meet the needs of simple to complex studies for large pharma as well as emerging biotech. Cenduit IRT deploys a full range of drug supply management functionality including industry leading, proprietary resupply algorithms, drug supply forecasting and optimization, temperature excursion monitoring and management, and drug accountability and returns management.  Cenduit IRT improves operational efficiency, reducing time and effort for sites and investigators allowing them to spend more time with patients.

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

Covance

Company Description:

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives. www.covance.com.

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

Endpoint

Company Description: Innovative IRT Specialists

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

ERT

Company Description: ERT is a global data and technology company that minimizes risk in clinical trials, helping sponsors bring treatments to patients quickly, with confidence. ERT’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/

IQVIA Technologies

Company Description: IQVIA (NYSE:IQV) is a leading global provider of advanced analytics, technology solutions and contract research services to the life sciences industry dedicated to delivering unique and actionable insights. Formed through the merger of IMS Health and Quintiles, IQVIA has approximately 65,000 employees worldwide. Learn more at www.iqvia.com.

Company Website: www.iqvia.com

PCM TRIALS

Company Description: PCM TRIALS screens, hires, trains and manages all of our own Certified Mobile Research Nurses who conduct clinical trial visits in the subject’s homes. Each nurse is trained, tested, and certified as a Certified Mobile on an annual basis in the principles of clinical trial research, GCP, Nurse Guidelines and IATA.  Services are available in U.S., Canada and ROW.

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

PRA Health Sciences

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

Synteract

Company Description: Bringing Clinical Trials to Life” represents Synteract’s commitment to engage with drug developers, patients, investigators, and regulatory experts, to bring insights to action and make better therapies a reality. Synteract supports biotech and pharma companies across all phases of drug development to help bring new medicines to market. Synteract has conducted nearly 4,000 studies on six continents and in more than 60 countries. It has contributed to more than 240 product approvals. Synteract offers a notable depth of expertise in oncology, general medicine, dermatology, neuroscience, pediatrics, and rare and orphan diseases.

Company Website: https://www.synteract.com/

Thread Research

Company Website:

UBC

Company Description: UBC provides integrated, comprehensive clinical, safety, and patient services. Our experts are committed to guiding sponsors through the product lifecycle and making therapies safer and more accessible. By powering expertise and experience with innovative tools, UBC stands out in the generation of real-world evidence of product safety, value, and effectiveness.

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

ICON

Company Description: Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of outsourced development and commercialisation services to pharmaceutical, biotechnology, medical device and government and public health organisations. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas. ICON has been recognised as one of the world’s leading Contract Research Organisations through a number of high-profile industry awards.

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

ACM Global

Company Website: http://acmgloballab.com/

Advance Research Associates

Company Description: Advance Research Associates is a premier provider of biostatistical and data management services to the pharmaceutical, biotech, and medical device industries. Since 1996, ARA has supported 700+ clinical trials worldwide across all therapeutic areas. Our collaborative approach helps maximize efficiency and agility by acting as an experienced member of your team.

Company Website: www.advanceresearch.com

Advanced Clinical

Company Description:

Advanced Clinical is a global clinical research services organization, providing CRO, FSP, Strategic Resourcing and Consulting Services for biopharmaceutical and medical device organizations. Our company is committed to improving all lives touched by clinical research and we address the hopes of patients and healthcare professionals with industry-leading services and technology in life sciences.  Visit our website to learn more about how we deliver a Better Clinical Experience.

Company Website: https://www.advancedclinical.com/

Agilex Biolabs

Company Description: Agilex Biolabs is the leading Australian Bioanalytical CRO providing regulated Bioanalysis to support clinical trials. We offer Bioanalysis for small molecules and biologics for PK, immunogenicity and biomarkers utilising the platforms of LC-MS/MS (7) and Immunoassay (MesoScale, Gyrolab). Agilex Biolabs operate a fully quality-assured, FDA-inspected laboratory (ISO/IEC17025 and OECD GLP).

Company Website: www.agilexbiolabs.com

AiCure

Company Website: http://aicure.com/

Almac

Company Description: The Almac Group is an established contract development and manufacturing organisation providing an extensive range of integrated services across the drug development lifecycle to the pharmaceutical and biotech sectors globally. Its innovative services range from R&D, biomarker discovery development and commercialisation, API manufacture, formulation development, clinical trial supply, IRT (IVRS/IWRS) through to commercial-scale manufacture. The international company is a privately owned organisation which has grown organically over the past five decades now employing over 5,600 highly skilled personnel across 18 facilities including Europe, the US and Asia. The company has a global reputation for excellence built over 50 years of client service, delivering expertise right across the drug development lifecycle and offering a tailored solution to each of our clients. To keep up to date with latest news, follow Almac Group on Twitter and LinkedIn or visit almacgroup.com.

Company Website: www.almacgroup.com

Altasciences

Company Description: Altasciences is a forward-thinking, mid-size contract research organization offering pharmaceutical and biotechnology companies of all sizes a proven, flexible approach to preclinical and early phase clinical studies, from lead candidate selection to proof of concept. For over 25 years, Altasciences has been integrating into clients’ projects to help support educated, faster, and more complete early drug development decisions. Altasciences’ full-service solutions include preclinical safety testing, clinical pharmacology, bioanalysis, program management, medical writing, biostatistics, data management and more, all of which can be tailored to specific sponsor requirements. Altasciences… helping sponsors get better drugs to the people who need them, faster.

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

Ancillare

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

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/

Catalyst Clinical Research

Company Description: Catalyst Clinical Research is a new generation Clinical Research Organization, serving  the unique needs of small-to-medium sized biopharmaceutical companies.  With locations in the US and EU, Catalyst offers highly flexible and customized, customer-centric solutions from Global Resourcing and FSP, to Full Service Managed Solutions, with a focus on oncology product development.

Company Website: http://catalystcr.com/

Celerion

Company Description:

With over 40 years’ experience, 600 beds and locations in NA, EU and Asia, Celerion conducts First-in-Human, clinical Proof-of-Concept and patient dose response studies, cardiovascular safety and NDA-enabling clinical pharmacology research. Celerion provides full study services including statistics, data management and biostatistics (including PK/PD analysis), and bioanalytical services.

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

Cerba Research

Company Description: Cerba Research provides the highest quality specialized laboratory and diagnostic solutions while leveraging patient data and scientific insight to shape and advance clinical trials. With our global footprint and access to leading regional labs, data, patients, technology, and partnered resources, we support global biotech, pharma, and IVD organizations to improve the lives of patients around the world.

Company Website: www.barclab.com

Clinipace

Company Description: Clinipace is a global, full-service CRO with a CHALLENGE ACCEPTED approach. We are collaborative and flexible, and provide personalized services and solutions, local regulatory expertise, and therapeutic leadership for your drug discovery projects.

Company Website: www.clinipace.com

CROMSOURCE

Company Description:

CROMSOURCE is an international contract research organization providing a comprehensive services to the pharmaceutical and biotechnology companies.  Specializing in clinical development and staffing solutions, we offer a flexible approach to ensure our clients’ unique needs are supported. CROMSOURCE is unparalleled in offering an end-to-end guarantee covering trial timelines, enrollment, and price.  CROMSOURCE operates offices across Europe and North America. 

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

EastHORN Clinical Services

Company Description: EastHORN Clinical Services is a European CRO with offices and operations reaching from Spain to Russia and everywhere in between. There is a strong emphasis on medical expertise which is a key factor in maintaining and developing long-standing relationships with sites. This confidence in the sites abilities and EastHORN's experienced Global Project Managers enable EastHORN to guarantee on-time and on-budget delivery.

Company Website: www.easthorn.com

Greenphire

Company Description: Greenphire is the industry leader of clinical payment technology, designed to improve the way research professionals work. We leverage our proprietary payments platform and workflow automation to help clients improve operational efficiency, reduce costs, mitigate regulatory risks, improve the patient and site experience and produce quantifiable results that improve clinical operations and strategic planning.

Company Website: http://greenphire.com/

KPS

Company Description:

KPS is a global, innovative, Clinical Outsourcing Provider delivering clinical trial monitoring, management and quality oversight services to pharmaceutical, biotechnology, medical device, and related industries.   Founded and operated as a more customer centric and nimblealternative to traditional CROs, KPS offers a full range of services leveraging the latest clinical technologies.

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

Longboat

Company Description: Longboat is a clinical technology solution for study teams, monitors, and site staff. Designed to help clinical trial staff to manage and track trials from start to end, Longboat provides tools for patient recruitment, consent, training site staff, monitoring engagement and performance, patient-specific walkthroughs, 21CFR Part11 communication tracking, and more.

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

Medpace

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

MedPoint Digital

Company Description:

MedPoint Digital develops intuitive, ICH-GCP compliant eClinical platforms for virtual investigator meetings, trial portals, interactive modules, and virtual clinical trials. Our digital solutions enable sites to be more productive, with online study training, study eBinders (eISF), digital study alerts and SUSARs, patient visit guides, and a wide range of study tools, available via web portals and mobile apps.

Company Website: www.medpt.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

MicroConstants

Company Description: MicroConstants is a GLP-compliant clinical and preclinical CRO (Contract Research Organization) focused on performing regulated bioanalysis, drug metabolism, and pharmacokinetic analysis in support of discovery, preclinical, and clinical drug development studies. We provide highly specialized services in method development, validation, and sample analysis for small molecules, macromolecules, biomarkers, and metabolites, using LC/MS/MS, HPLC/UV, immunoassay, multiplex, and qPCR techniques. We also assemble and distribute protocol-specific specimen collection kits to streamline and simplify the PK collection process for single and multi-site clinical trials.

Company Website:

Montrium

Company Description: Montrium is a global leader in electronic content management solutions and GxP consulting services for the life sciences. With a deep understanding of the clinical research and drug development arena, our team has developed a range of intelligent and dynamic solutions to provide a best-in-class customer experience. eTMF Connect, Montrium’s electronic trial master file solution, centralizes and standardizes clinical records to enable sponsors and CROs to streamline study start-up, conduct and close-out activities in the cloud. Montrium is headquartered in Montreal, Canada with a European office in Brussels, Belgium.

Company Website: www.montrium.com

Nucleus Network

Company Description: Nucleus Network is Australia’s largest Phase 1 clinical research organisation and the only Phase 1 specialist globally with phase I facilities in the US and Australia.  Our Australian phase I facilities are in Melbourne and Brisbane, and our US phase I facility is located in Minneapolis. Combined, our clinics offer over 200 beds. All three clinics are strategically co-located within leading medical, research and biotech precincts offering unique access to ancillary services including bioanalytical laboratories, MRI, lumbar punctures, chest X-rays, ophthalmology assessments and others.  Since our establishment in 2004, we have conducted over 700 phase I clinical trials, with 80% of our clients consisting of US based biotech and pharmaceutical companies.  We have access to a population of over 10.5 million people across all 3 sites, and the ability to offer a multi-site solution in recruiting participants and patients to our clients.  Together with our client partners, we are fulfilling our purpose of ‘Advancing medicine, improving lives.’

Company Website: www.nucleusnetwork.com.au

Pharm-Olam International

Company Description:

Pharm-Olam International delivers cost effective, quality clinical services to pharma and biotech sponsors across all therapeutic areas in more than 40 countries.  Since 1994, we have been committed to our objective: to create value for our clients by satisfying their clinical development needs with consistent and dependable solutions and services.

Company Website: http://www.pharm-olam.com/

PRC Clinical

Company Website: http://www.prcclinical.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

Prevail

Company Description: Prevail InfoWorks improves the probability of clinical trial success by providing stakeholders real-time actionable intelligence to effectively manage endpoints and key deliverables with the Single Interface™, its patented cloud-based tool that aggregates, reconciles, analyzes and single-view reports/visualizes all clinical, operational and project accounting data, regardless of the source or format.

Company Website: www.prevailinfoworks.com

Statistics & Data Corporation (SDC)

Company Website: http://www.sdcclinical.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

Teckro Limited

Company Description: Founded in 2015 Teckro provides solutions to simplify and modernize clinical research for leading pharmaceutical and emerging biotech companies. To date, Teckro manages more than 100 clinical trials and is used by more than 11,800 active study sites around the world. Teckro employs more than 100 staff across its global headquarters in Limerick, Ireland, engineering excellence hub in Dublin, Ireland and its US-based office in Nashville, Tennessee. Visit www.teckro.com for more information.  

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

TransPerfect

Company Description:

As a global leader in business services for over 20 years, TransPerfect is a woman-owned, privately held company with over 90 offices globally on six continents. Since its inception, TransPerfect has been supporting life sciences in the conduct of global clinical development, commercialization and life cycle management of products catering to the health care community.

Company Website: www.transperfect.com

UR Central Labs

Company Website: www.CentralLabs.urmc.edu

WCCT Global

Company Description:

WCCT Global is a multi-site, full service CRO of outsourced early drug development and late phase services to the pharmaceutical, biotechnology and medical device industries. WCCT has extensive experience with healthy volunteer studies including First-in-Human, as well as specific therapeutic expertise in Allergy, Asthma, HCV, Ophthalmology, Oncology, Renal, and Vaccines.

Company Website: http://wcct.com

YPrime

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

Invicro

Company Description:

We are the quantitative imaging experts working across the entire drug development spectrum to better diagnose, characterize, treat and cure disease. Invicro is leading innovation to elucidate biological processes for our pharmaceutical and biotechnology partners around the world. www.invicro.com

Company Website: www.invicro.com

ProTrials Research

Company Description: We are a clinical research organization serving the pharmaceutical, biotechnology and device industries for more than 20 years, ProTrials professionals provide one of the industry’s highest average years of experience - you can trust us to understand your requirements, whether you hire a single staff member on a consulting basis or retain an entire team of experienced monitors in the field. We offer a suite of services focused on clinical operations experience:

• Experience in a broad range of therapeutic areas
• Phase I-IV clinical trials
• Highly-skilled project management services

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

QPS

Company Description: QPS is a global contract research organization (CRO) providing discovery, preclinical and clinical drug development services since 1995. Our mission is to accelerate pharmaceutical breakthroughs across the globe by delivering custom-built research services. An award-winning leader focused on bioanalytics and clinical trials, QPS is known for proven quality standards, technical expertise, a flexible approach to research, client satisfaction and turnkey laboratories and facilities. We are passionate about our work, creating value for patients and customers while generating opportunities for employees to thrive.

Company Website: www.qps.com

Cmed

Company Website:

Target Health

Company Website: