Outsourcing in Clinical Trials Southeast 2022

Pro-ficiency

Company Description: Pro-ficiency converts training from a cost center to a powerful quality improvement system. Our simulation-based protocol training prevents study errors, guarantees timely SIV, and frees up thousands of hours for your study team and site-staff. Pro-ficiency ensures that everyone in your study is compliant with all training requirements.

Company Website:

ICON

Company Website: www.iconplc.com

Medable

Company Description: Medable offers the most flexible decentralized clinical trial platform – streamlining trials for patients, sites, and clinicians whether in-clinic or at home. Medable’s completely modular approach allows pharmaceutical companies and clinical research organizations (CROs) to use only what they want, while scaling capabilities to better suit their unique studies.

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

SiteBridge Research

Company Description: SiteBridge Research is an integrated research organization, building a national network of community practices to deliver world-class industry sponsored clinical research on-time and on-budget, accelerating time to market and product adoption in communities that are historically the most vulnerable and the hardest to reach, including those of color and other medically marginalized groups. The SiteBridge network extends reach further into these communities to empower a broader set of patients with some of the highest unmet needs to take part in clinical research to improve health outcomes.

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Syneos Health

Company Description: Syneos Health (Nasdaq:SYNH*) is the only fully integrated biopharmaceutical solutions organization. Our company, including a Contract Research Organization (CRO) and Contract Commercial Organization (CCO), is purpose-built to accelerate customer performance to address modern market realities. Created through the merger of two industry leading companies – INC Research and inVentiv Health – we bring together more than 21,000 clinical and commercial minds with the ability to support customers in more than 110 countries. Together, we share insights, use the latest technologies and apply advanced business practices to speed our customers’ delivery of important therapies to patients. To learn more about how we are shortening the distance from lab to lifeTM visit SyneosHealth.com. 

Company Website: www.SyneosHealth.com

TrialCard

Company Description: TrialCard Incorporated is a full-service life sciences commercialization partner that provides comprehensive solutions that span the entire biopharmaceutical value chain. In addition to a foundation of fully integrated, digitally enabled patient support services, its broader offerings include everything from late-stage clinical trial management to post-marketing HCP engagement services and proprietary data-as-a-service payer intelligence and insights. Founded in 2000, TrialCard provides commercialization needs for more than 160 life science customers and has connected over 35 million patients with more than $18 billion in branded drug savings to date. The company is headquartered in Morrisville, North Carolina.

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

Viedoc

Company Description: Viedoc designs engaging software for the life science industry. By accelerating clinical trials on all levels, our solutions support major pharmaceutical, biotech, and medical device companies, as well as renowned research institutions worldwide. Headquartered in Uppsala, Sweden, Viedoc also has offi ces in America, France, Japan, Vietnam, and China. Since our inception in 2003, over 1 million patients in more than 75 countries have participated in studies powered by Viedoc. www.viedoc.com

Company Website: www.viedoc.com

Worldwide Clinical Trials

Company Description: Worldwide is changing how the world experiences CROs – in the best possible way. From early phase, bioanalytical sciences, late phase, post-approval and real-world evidence, Worldwide Clinical Trials provides full-service drug development services for central nervous system, cardiovascular, metabolic, general medicine, oncology and rare disease therapies.

Company Website: www.worldwide.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

ACM Global Laboratories

Company Description: ACM Global Laboratories is one of the largest global independent central labs in the industry. ACM is certified by the College of American Pathologists (CAP) and the Substance Abuse and Mental Health Services Administration (SAMHSA). The company delivers high-quality laboratory testing and diagnostic lab services in support of both clinical trials research, toxicology and individual patient care. ACM provides a powerful combination of operational excellence, scientific expertise and unsurpassed global service to customers in more than 65 countries. ACM performs more than 20 million laboratory tests each year—spanning all medical disciplines including pathology, microbiology, molecular diagnostics, toxicology and more.

Company Website: www.ACMGlobalLab.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

assisTek

Company Description: assisTek has been paving the way for integrating technology and data collection in clinical trials for over 25 years. We have earned a solid reputation around the globe by delivering customized solutions used in over 500 clinical research trials, across 90 different languages in 80 different countries. Based outside Philadelphia, Pennsylvania, we pride ourselves on being boutique by design and always customer focused. eCOA is our core focus but not our only service. Our experienced team has been in this niche of clinical research with deep domain experience for decades and client solutions has been our passion for over two decades.

Company Website: www.assistek.com

Axiom Real-Time Metrics

Company Description: For more than 20 years, Axiom has delivered data-driven, powerful and cost-effective eClinical Solutions and Services dedicated to small-to-medium life science companies. Fusion eClinical Suite is the most adaptable, unified platform that serves as the Connected Hub for all your Clinical Trial and operational data and reporting. Choose from over 15 fully integrated modules on a single platform: EDC, DM, RTSM/IWRS, CTMS, Inventory Management, ePRO, eConsent, Patient Portal, AE/SAE Tracking, Safety Database, Central/Local Lab, Imaging Management, eTMF, and 24/7 Project and Clinical Data Reporting. We are an embedded partner dedicated to the success of your study, offering managed services such as: Data Management, On-Demand Data Analytics, Biostatistics, Clinical Management, eTMF Management and Pharmacovigilance.

Company Website: http://www.axiommetrics.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

Clincierge

Company Description: Clincierge reduces barriers to trial participation by employing patient-centric strategies to enhance the patient experience, increase patient retention, and improve clinical trial performance. We provide personalized patient logistics management, reimbursement, and convenience services to support clinical trial participants. This enables earlier submissions with the potential of coming to market sooner and recovering R&D investments ahead of projections. 

Company Website: www.clincierge.com

ClinOne

Company Description: ClinOne, a leader in virtual clinical trial management, provides a single platform technology experience to accelerate clinical trial enrollment and remote patient care, compliance and retention. Featuring solutions for automated referrals, eConsent, patient engagement, connected devices, eCOA, and eSource, ClinOne makes participating in a clinical trial a little easier, every day. Learn more at www.clinone.com.

Company Website: www.clinone.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/

Eurofins BioPharma Services

Company Description: Eurofins BioPharma Services, Laboratory Testing is a group of Eurofins companies with dedicated testing facilities for global Central Laboratory Services, Bioanalytical Services, and Specialty Virology and Oncology Services.  We provide one of the broadest testing portfolios in the industry and this includes Safety & Efficacy testing, Biomarkers & Flow Cytometry, Cell based assays, Oncology/Pathology, Genomics, Virology, Immunology, Microbiology, Bioanalytical Services, early clinical development service and clinical trials supply. Company Website: https://eurofinscentrallaboratory.com/biopharma-services/

Company Website: eurofinscentrallaboratory.com/biopharma-services

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/

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

MLM Medical Labs

Company Website: http://www.mlm-labs.com

MyData-TRUST

Company Description: The aim of MyData-TRUST consists in supporting the Life Sciences Industry in leveraging their compliance related to Data Protection. We are providing a services and solutions aligned with both Health R&D and Data Protection requirements (GDPR, HIPAA, Privacy Shield).

Company Website: www.mydata-trust.com

NCGS Inc.

Company Description: NCGS, Inc. is a full-service, global CRO. Since 1984 we have helped with 58 approved products and have ZERO 483s or other warnings from the FDA, EMEA, or other global agencies. We offer Sponsors only tenured teams with very low turnover, making each clinical effort more quality-based, thorough, timely and cost-effective.

Company Website: https://www.ncgs.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/

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

Philips BioTel Research

Company Description:

Philips BioTel Research is an industry leader in medical imaging and cardiovascular safety testing for clinical trials.

Philips BioTel Research offers global operational support for cardiovascular monitoring in all therapeutic areas, and advances imaging services in oncology, cardiovascular, metabolic, musculoskeletal, neurologic, and medical device studies. Their experienced research team comprises key opinion leaders, board-certified cardiologists and radiologists, sub-specialty scientists, and highly trained technicians – who acquire, evaluate, and report high-quality data through an efficient, cloud-based infrastructure. Many biopharmaceutical trial sponsors rely on or scientific leaders to help design and optimize their protocols and statistical analysis plans. We have conducted clinical trials contributing to the market approval of nearly 100 new drugs to date.

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

Premier Research

Company Description: Premier Research is a leading clinical development service provider that helps highly innovative biotech and specialty pharma companies transform breakthrough ideas into reality. The company has a wealth of experience in the execution of global, regional and local clinical development programs with a special focus on addressing unmet needs in areas such as analgesia, CNS, oncology, pediatric, and rare disease.

Company Website: http://www.premier-research.com/

ProPharma Group

Company Description: ProPharma Group is the global, independent, single-source provider of regulatory and compliance consulting, clinical research services, pharmacovigilance, and medical information serving pharmaceutical, biotechnology, and medical device companies. Founded in 2001, ProPharma Group has more than 1900 colleagues worldwide providing a comprehensive portfolio of regulatory, clinical and compliance solutions to help solve complex challenges in a dynamic regulatory environment. With the mission to improve the health and safety of patients, ProPharma Group is focused on delivering the highest quality of services throughout the full product lifecycle. For more information, please visit www.propharmagroup.com.

Company Website: www.propharmagroup.com

Spencer Health Solutions

Company Description:

Spencer Health Solutions, transforming the patient experience, from the home. The spencer® device brings together medication dispensing, daily patient engagement, telehealth, real-world data collection and analytics where they matter most – the patient’s home. The spencer smart hub is a game-changer for pharmaceutical partners by enhancing end-to-end patient support.

Spencer Health Solution’s vision is to create the future of connected care. Built from the ground up as a patient engagement platform, the spencer smart hub connects patients and their care teams with a fully integrated medication management device.

Company Website: www.spencerhealthsolutions.com

Statistics & Data Corporation (SDC)

Company Description: SDC delivers top-tier clinical trial services to pharmaceutical, biologic and device/diagnostic companies.  With strategic scientific consulting and clinical data services (biostatistics, data management/EDC, and IRT/WRS) expertise at our core, our services are scalable via our strategic partnerships to provide full-service clinical trial solutions that are The Right Fit For You.

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

Tower Cold Chain Solutions

Company Description: Tower Cold Chain provide temperature-controlled solutions to the global pharmaceutical and life science industries. We have been working with businesses since 2007 to safeguard products and we understand what our customers and their markets need to create value within their supply chain. It is our vision is to be the number-one cold-chain shipping facility of choice. By collaborating with our customers, we provide solutions to transport products safely, whenever and wherever needed. Robust: Ensuring product integrity for your patients Reliable: Delivering pharmaceuticals to patients when and how they need them. Reusable: Efficient and effective results for our global customers

Company Website: www.towercoldchain.com

Trilogy Writing & Consulting

Company Description: At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. We proactively plan, coordinate and write clinical documents to meet timelines, with a readability that reduces the time for review and approval.

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

ADVARRA

Company Description: Advarra integrated solutions connects life sciences companies, CROs, research sites, investigators, and academia at the intersection of safety, technology, and collaboration. With the most trusted review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra optimizes research performance, empowers clinical sites, and ensures compliance.  Advarra advances the way clinical trials is conducted to make them safer, smarter, and faster.  

Company Website: www.advarra.com

Endpoint

Company Description: Innovative IRT Specialists

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

Viroclinics-DDL

Company Description: Viroclinics-DDL, a Cerba Research Company is a leading specialty contract research organization, serving the biopharmaceutical community with a broad range of non-clinical research, clinical diagnostics, assay development, laboratory, and clinical trial logistic services. It offers its clients a global reach through a network of 38 processing laboratories. More Info: www.viroclinics.com www.ddl.nl

Company Website: www.viroclinics.com