Outsourcing in Clinical Trials East Coast 2021

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/

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

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

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/

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

DHL

Company Description: The DHL clinical trials logistics service encompasses the key stages of the supply chain. Services include inbound receipt of bulk IMPs, storage of IMPs and lab ancillaries within state of the art GMP facilities (-160oc, -20oc, 2-8oc, 15-25oc), secondary packaging, lab kit production, transportation and management of return flows (i.e. unused medication, kits or specimens). Distribution to investigator sites in over 80 countries around the world is through a global depot and integrated carrier network optimized to meet trial needs. DHL manages clinical trials logistics through dedicated study managers and bespoke clinical trials information systems. Website - DHL LIFE SCIENCES & HEALTHCARE EXPERTISE

Company Website: http://www.logistics.dhl/global-en/home/our-divisions/supply-chain/sectors-overview/life-sciences-and-healthcare/our-life-sciences-and-healthcare-expertise.html

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

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/

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/

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

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/

THREAD

Company Website:

TrialCard

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

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

YPrime

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

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/

Ancillare

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

ABF Pharmaceutical Services GmbH - Member of the GBA GROUP PHARMA

Company Website:

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/

Choice TeleMed

Company Description: Choice TeleMed provides Innovative Medical Imaging services globally through its network of industry leading UK physicians to support clinical trials. We partner with Pharma, CROs, sponsors and sites to alleviate trials' imaging pinch points, offering a range of solutions including reading/reporting, secure end-to-end management, expedited medical physics (MPE/CRE reviews), trial protocol design and imaging AI integration.

Company Website: www.choicetelemed.co.uk/clinical-trials-imaging

Clinical Solutions Group

Company Description:

Clinical Solutions Group is centered around biopharma solutions with a 19-year track record of delivering high-quality consulting and service offerings to top-tier drug development companies.

Company Website: www.csg-inc.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/

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/

FMD K&L

Company Description: Celebrating our 25th anniversary in 2020, FMD K&L is a global Contract Research Organization supporting Data Management, Biostatistics, Statistical Programming, Clinical Operations, Regulatory Affairs, Safety, Pharmacovigilance, Toxicology, Medical Affairs, Medical Writing, Quality, Risk, and Compliance services to the Pharmaceutical, Biotechnology, and Medical Device industries worldwide.

Company Website: http://www.klserv.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/

Inspire

Company Description: Inspire is a vital health community where more than two million patients and caregivers feel comfortable sharing personal health data, experiences, and answering questions candidly. By tapping into patients’ rich and varied health journeys on Inspire, researchers and health practitioners around the world are advancing treatments and making breakthrough discoveries. Combining patient-reported health data, personal medical records, and conversations in the Inspire community uncovers critical insights unattainable with traditional research methodologies. Through Inspire you will access a unique blend of data longitudinally across patients’ health journey to draw insights that accelerate medical progress and improve healthcare.

Company Website:

Oracle Health Sciences

Company Description:

Oracle Health Sciences

Oracle is a leading strategic software solutions provider to the health sciences industry, helping pharmaceutical, biotechnology, medical device, and healthcare organizations become the most successful in the world by offering the most innovative products and services that deliver the most compelling customer and shareholder value. Oracle's comprehensive industry solutions include clinical trial management and analysis, electronic data capture, adverse event reporting and pharmacovigilance, and healthcare interoperability. Oracle partners with health sciences industry leaders – including 20 of the top 20 life sciences companies and 14 of the top 14 Fortune Global 500 healthcare organizations – to prevent and cure disease, enhance quality of life, and accelerate insights for better health.

Company Website: http://www.oracle.com/us/industries/health-sciences/overview/index.html

PCI Clinical Services

Company Description: PCI Pharma Services is an integrated full service provider, a proven and trusted partner to leading companies in the global healthcare industry. We offer unparalleled expertise and experience in taking compounds from the earliest stages of development through to successful commercialization, delivering speed-to-market and commercial success for our customers.

Company Website: http://www.pciservices.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/

Peachtree BioResearch Solutions. Inc.

Company Description: Peachtree BioResearch Solutions is an Atlanta-based Clinical Research Organization that provides clinical development support services and innovative resourcing solutions to medical device, pharmaceutical, and biotech companies. We are committed to delivering high-quality, cost-effective services according to sponsor timelines and specifications. Flexible. Scalable, Reliable. We’re your solution.

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

Phase Clinical Services

Company Description: Phase Clinical Services is a full service CRO focusing on Phase 0-II oncology clinical trials.  Exclusive overseas access to 51,000 oncology patients per year, close collaboration with top government officials and effective local teams ensure successful trial completion.  Exceptionally competitive rates and clinical trial management from New York City.

Company Website: www.phaseclinical.com/

Reify Health

Company Description: Reify Health provides cloud-based software that accelerates the development of new and life-saving therapies. Reify serves the global life science industry, including thousands of clinical research sites, the most innovative biotechs, and the world’s largest biopharmaceutical companies. To learn more, visit www.reifyhealth.com.

Company Website:

SDL

Company Description: SDL is a global leader in content creation, translation, and delivery. Meet us to learn how to achieve the digital transformation necessary to take your content global and deliver upon the promise of Artificial Intelligence and Machine Learning for advancing multilingual content that results in highly optimized operations. SDL leads the industry in reducing costs across the content supply chain and provides the most complete breadth of end-to-end linguistic solutions across the full lifecycle of clinical development, from discovery and product development (Pre-Clinical & Phases I to III), to regulatory submission (EMA/FDA compliance) and commercialization (Phase IV/Sales and Marketing).

Company Website: www.sdl.com

SGS

Company Description: SGS is a leading life sciences CRO providing clinical research and bioanalytical testing with a specific focus on early stage development and biometrics. Delivering solutions in Europe and in Americas, SGS offers clinical trial (Phase I to IV) services encompassing full early phase drug development consultancy, clinical project management and monitoring, biometrics, PK/PD modeling & simulation and regulatory & medical affairs services. SGS has its own clinical unit in Belgium including a viral challenge testing facility and two phase I patients units based in Belgium and Hungary. SGS has a wealth of expertise in FIH studies, viral challenge testing, biosimilars and complex PK/PD studies with a high therapeutic focus in Infectious Diseases, Vaccines, and Respiratory.

Company Website: http://www.sgs.com/en/life-sciences/clinical-research-services

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

United Language Group

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

WCCT Global, an Altasciences company

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

WCG IRB

Company Description: With more than 200 experienced members on our AAHRPP-accredited boards, and more than 50 years of experience in protocol and study-related review, WCG IRB brings more expertise to the industry than any other ethical solutions provider.

Company Website:

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

Navitas

Company Description: Navitas Life Sciences has 120,000+ volunteers, 1100+ BABE studies, 120+ Industry Networks members, 20+ therapeutic area expertise, 550+ clinical trials and proprietary OneClinical Analytics platform, making it the preferred partner, with an average 12 years of active association with 15 of the top Global pharmas.

Company Website: www.navitaslifesciences.com

Complion

Company Description: Complion’s eRegulatory document and workflow management platform improves efficiency, compliance and transparency for research sites and sponsors. It stores, organizes and routes all regulatory documentation involved in a clinical trial. Complion has garnered overwhelming industry support and has been accessed by more Sponsors and CROs than any other eRegulatory platform.

Company Website: www.complion.com

EASi Sciences

Company Description: Amazing begins here. EASi is a leading global services company specializing in sciences. For more than 35 years, our team has brought a passion for innovation to deliver critical services and cutting edge solutions. EASi has 3,700 dedicated employees across North America, Europe and Asia.

Company Website: www.EASi.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/

Flywheel

Company Website:

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

Komodo Health

Company Description:

Company Website:

Medpace

Company Website: http://www.medpace.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

Miller Tanner Associates

Company Description: Miller Tanner Associates is a WBENC-certified, full-service global corporate event planning company specializing in the life sciences industry for over 23 years (10+ in virtual events). We deliver exceptional experiences for face-to-face, virtual, and hybrid meetings and events as well as tailored event management technology solutions including proprietary tools - EPIC™, Attend™, and VALTs™. We offer a broad spectrum of products and services to support event planning needs, including security and compliance (21CFR Part 11), engagement strategies, technology support, robust pre- and post-event reporting and more. To learn more about Miller Tanner Associates, visit www.millertanner.com.

Company Website: millertanner.com

PSN Research

Company Description: PSNResearch is a unique international mid-size CRO offering a Full-Service support (from Reg. submission to final study report writing, all phases exploratory & confirmatory, as well as post-marketing and Early Access programs) to Biotechs/Medtechs and Pharmas, for over 20 years now. Our expertise includes drugs, vaccines, biologics, cell & gene therapies, ATMP, diagnostics and medical devices with recognized experts.

Company Website: www.psnresearch.com/

Statistics & Data Corporation (SDC)

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

WorldCare Clinical

Company Description: WorldCare Clinical, LLC (WCC) is a global imaging CRO that provides sponsors with extensive medical, operational and image management expertise in support of even the largest and most complex study designs. Whether it's for a clinical trial in the pharmaceutical, biotechnology or medical device industry, WCC's highly-trained, global core lab team provides end to end imaging services and unparalleled radiology expertise. Leveraging in-house trial experts and strategic relationships with world-class, subspecialty trained board-certified physicians,, we provide customized solutions that ensure a successful trial process and outcome

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