Xtalks Event Sponsorship Opportunities

Established in 1968, Analytical Bio-Chemistry (ABC) Laboratories, Inc. is a Contract Research Organization that delivers a broad array of product development and analytical testing services to the pharmaceutical, biotech, animal health, and chemical industries. The company supports all stages of large and small molecule drug development with expert analytical support, custom synthesis and radiolabeling, environmental assessments and drug development consulting services.

ACM Global Central Lab offers a flexible approach and a focus on precision to optimize the clinical study outcomes for our clients.ACM Global’s services extend to more than 60 countries, with all tests conducted and managed from central lab facilities and a seamless data management process providing a single global database. ACM performs 20 million diagnostic tests each year, offering more than 1,500 individual assays, spanning virtually all medical disciplines, including pathology, microbiology, flow cytometry, and pharmacogenomics. Combining comprehensive safety, efficacy and pathology testing from a single lab ensures clients receive consistent, accurate test results with faster and cleaner reporting.

Providing a wide range of drug development and clinical trial supply services, Almac assists global Pharma and Biotech companies reach their critical clinical milestones and ultimately commercialisation.

Offering innovative pharmaceutical development services for solid oral dose drug products, Almac can work with client partners to produce an optimum formulation and manufacture clinical batches from initial First in Human supplies to phase IV / registration.  Following your protocol designs, Almac can additionally provide a range of solutions for blinding and over-encapsulation from single tablet filling to multiple mixed input units and controlled powder / excipient dosing.

Archimedes is a Healthcare Modeling company that has built a large scale simulation model of physiology, disease, interventions, and healthcare systems.

For more than 35 years, Bend Research has worked with clients to create value by advancing new medicines that improve human health and to solve their most difficult scientific and technical problems. This success is based on the company’s ability to develop, advance, and commercialize pharmaceutical technologies, which grow from a solid base of scientific and engineering fundamental understanding.

Caprion is a world leading provider of proteomics-based biomarker services and immune monitoring solutions to the pharmaceutical and biotech industries.

Caprion has recently acquired the assets of the National Immune Monitoring Laboratory (NIML) and now provides immune monitoring capabilities under the IMMUNECARTA brand. Services include analysis of phenotypic and functional profiles of innate and adaptive immune responses in a GLP/GCLP compliant environment.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. With over 75 years of experience, we have the deepest expertise, the broadest offerings, and the most unique technologies to help you get more molecules to market faster, enhance product performance and provide superior, reliable manufacturing and packaging results.

Catalent. More products. Better treatments. Reliably supplied.™

ClinStar is a Western managed CRO with local operations in Russia, Ukraine, Belarus and the Baltics. We have 12 years of experience in Phase I-IV clinical trials across multiple therapeutic areas. Unlike many global CROs, we offer a substantial local presence across all areas of operations, providing us with unique local knowledge and personal relationships that benefit your clinical trial.

Copernicus Group IRB (CGIRB) is an independent institutional review board (IRB) whose primary responsibility is to ensure that the rights and welfare of human research subjects are protected.

The CGIRB Board reviews research protocols and study-related information, as well as investigator qualifications and resources to assure regulatory compliance. Copernicus Group IRB may review studies for a single investigator or serve as a central IRB for multi-center trials involving upwards of several thousand investigators.

Covance, with headquarters in Princeton, New Jersey, is one of the world's largest and most comprehensive drug development services companies, with annual revenues greater than $2 billion and more than 11,000 employees in more than 60 countries. Covance has the people, processes, client service, and global resource capabilities to respond to biotechnology and pharmaceutical clients' toughest drug development challenges.

DVS Sciences, Inc. is an analytical equipment and reagents development company that produces and markets globally the CyTOF™ , a high throughput mass cytometer for individual cell analysis based on a novel elemental mass-spectrometry detection technology, and the MAXPAR™ system of novel reagents related to massively multi-parametric biological assays.

Emerald Bio is a protein resource company. We are leveraging our unique assets and know-how in protein biochemistry and structural biology to bring our customers our protein resource operating system. The Emerald Bio Protein Resource Operating System (PROS) furthers our clients' understanding of proteins ultimately leading to improved human health. Emerald Bio is a privately-owned company that maintains facilities in the Seattle and Boston areas. Our dedicated teams support leading research institutes and commercial therapeutic and diognostic companies worldwide. Emerald Bio has deposited over 500 protein structures in the Protein Databank and delivered as many proprietary structures to our clients. Emerald has also catalogued over 1500 protein constructs into a Protein Information Management System and contributed to the submission of two NCEs since 2011. By leveraging our expertise, insight and resources for protein science, we provide solutions for your next challenging protein project.

Fisher Clinical Services is the world's leading provider of clinical supply chain services. With a network of cGMP facilities strategically located across the globe to support the conduct of clinical trials, we offer worldwide support for all aspects of clinical supply management including comparator, co-medication and ancillary supply sourcing, packaging, labeling, distribution, storage, through to returns and destruction. With more than 20 years of experience exclusively focused on clinical trials, we can offer guidance and full logistics support across all types of clinical programs and projects.

Fujifilm Diosynth Biotechnologies is an industry leading Biologics Contract Development and Manufacturing Organization with locations in USA and UK. With extensive experience in the development and manufacture of biopharmaceuticals expressed in a wide array of systems, we offer a comprehensive list of services from cell line and strain development, including our proprietary pAVEway™ and CHO cell line systems, to process development, analytical development, clinical and commercial manufacturing.

INC Research is a therapeutically focused contract research organization with a high performance reputation for conducting global clinical development programs of the highest integrity. Pharmaceutical and biotechnology companies look to INC Research for a complete range of customized Phase I through Phase IV programs in therapeutic areas of specialty, and in innovative pediatric and women's health trials. The company's The Trusted Process® methodology and therapeutic foresight leads customers to more confident, better-informed drug and device development decisions. INC Research is headquartered in Raleigh, North Carolina.

Institutional Review Board Services™ (IRB Services), established in 1993, is a wholly independent company with ethics boards and knowledgeable staff in both Canada and the USA. We are the only independent IRB designated by the Minister of Health to review research in the province of Saskatchewan.

Founded in 1985, JSS Medical Research Inc. is a Contract Research Organization that manages Phase I to Phase IV trials and specializes in Outcomes Research on behalf of pharmaceutical, biotech and nutraceutical companies. The organization responds to the evolving needs of the stakeholders in the healthcare field for high quality, scientifically rigorous and sound clinical research services.

LabCorp Clinical Trials a division of LabCorp, combines standardized international laboratory capabilities with sophisticated diagnostic technologies to provide a broad portfolio of services and clinical assays to support drug and diagnostic clinical studies.

With a proven track record of providing quality scientific solutions for 19 of the top 20 largest pharmaceutical/biopharmaceutical companies in the world, Lancaster Laboratories is a global leader in bio/pharmaceutical laboratory services providing innovative and timely scientific solutions to streamline the drug development process.

For over 30 years, Lonza Custom Manufacturing has been helping emerging and established biotech and pharmaceutical companies improve and successfully advance their products to the next level. Whether for clinical or commercial supply, Lonza’s full set of development services, industry-leading manufacturing processes, and broad chemical and biotechnology platforms enable you to reach your clinical milestones earlier.

REGISTRAT-MAPI provides strategic and operational solutions for our clients in the design and implementation of Late Phase studies. We are the pharmaceutical industry’s largest global CRO dedicated exclusively to real world clinical research. With more than 250 experienced professionals, we have served the biopharmaceutical and medical device industries for more than 20 years.

Max Neeman International is a leading India-centric Contract Research Organization and the wholly-owned clinical research subsidiary of Max India Limited, reputed business group with interests in healthcare, clinical research and life insurance. For over a decade, Max Neeman has offered customized services to global pharmaceutical, biotech and device companies in the conduct of clinical and device trials as well as data management. Operational since 2001, Max Neeman is an ISO certified CRO for Site Management, Monitoring, Data Management, Information Security Management Systems and Clinical Investigation of Medical Devices with 6 regional offices, 175 sites across 31 cities, headquarters in New Delhi and USA office based in Cary, North Carolina.

Medidata Solutions is a leading global provider of cloud-based clinical development solutions that enhance the efficiency of customers’ clinical trials. Medidata’s advanced platform lowers the total cost of clinical development by optimizing clinical trials from concept to conclusion: from study and protocol design, trial planning and budgeting, site negotiation, clinical portal, trial management, randomization and trial supply management, clinical data capture and management, safety events capture, medical coding to business analytics. Our diverse life science customer base spans biopharmaceutical companies, medical device and diagnostic companies, academic and government institutions, CROs and other research organizations, and includes more than 20 of the top 25 global pharmaceutical companies as well as organizations of all sizes developing life-enhancing medical treatments and diagnostics.

With global headquarters in Mattawan, Michigan, MPI Research is a preclinical, contract research organization that provides discovery, safety evaluation, bioanalytical, and analytical services to the biopharmaceutical, medical device, animal health, and chemical industries. Responsiveness, scientific knowledge and experience, integrity, trust, teamwork, and dedication to strong and enduring Sponsor relationships are the defining attributes that characterize MPI Research as a high-performance, high-quality organization that is committed to bringing safer and more effective products to the world.

OmniComm Systems, Inc. is dedicated to helping the world’s pharmaceutical, biotechnology, CROs, research and medical device organizations maximize the value of their clinical research investments through the use of innovative and progressive technologies.

Our Electronic Data Capture (EDC) and eClinical technologies have been used in over 3,000 clinical trials around the globe.

Orbis Biosciences revolutionizes the delivery, efficacy, and safety of products in the pharmaceutical, food, consumer product, and specialty chemical industries. Orbis’ technology platform, Precision Particle Fabrication, provides the ability to precisely control the release of active ingredients. This patented technology enables new products and reduces costs across these industries.

PharmaNet/i3, in the inVentiv Health clinical segment, is recognized as a leading provider of global product development services to pharmaceutical, biotechnology, generic drug, and medical device companies, offering therapeutically specialized capabilities for Phase I-IV product development, bioanalytical services, and staffing from a single clinical professional to an entire functional team. For intelligent solutions needed to accelerate high quality product development programs of all sizes around the world, PharmaNet/i3 works for you.

PharmInvent is a fast growing company which provides professional services in areas of pharmacovigilance, regulatory affairs and drug development to help pharmaceutical and biotechnology companies develop and commercialize their products. Our clients benefit from our unique expertise and insight into the European Medicines Agency, CHMP, CMDh as well as key national authorities in Europe.

PPD is a global contract research organization (CRO) providing discovery, development and lifecycle management services. With offices in 45 countries and more than 11,500 employees worldwide, PPD has conducted clinical trials in over 100 nations, and we have worked with all of the top 50 pharmaceutical companies.

As a leading CRO, PRA is transforming clinical trials through our people, innovation and operational transparency. We combine therapeutic and operational expertise with local knowledge to serve clients across all phases of drug development. With 40 drug approvals to date, PRA has an impressive therapeutic background that encompasses a variety of compounds, ranging from niche treatments to blockbuster drugs and biosimilars.

At Premier Research we focus on doing what we do best, and on putting all the pieces together to take our customers from proof of concept to regulatory approval. To do that, we have developed a surprising concentration of experience for a mid-sized CRO.

For the future, we plan on continuing to focus on serving the needs of the small, highly innovative pharmaceutical and biotechnology companies whose developments are changing medical history, especially in the areas of pediatric medicine and rare diseases. We will offer them everything they need to transform brave new ideas into life-saving therapies.

Quintiles helps you navigate the complexities of early-phase trials with scientific expertise, innovative approaches and flexible solutions to ensure smarter, faster trials. So you get the insights you need to confirm compound viability, identify risks and make go/no-go decisions with speed and confidence. Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant.

SenseAware^SM powered by FedEx is a technological breakthrough in the world of sensor-based logistics. SenseAware integrates an advanced multi-sensor device that travels inside your shipments with a powerful web-based application, providing near real-time access to your shipments’ current location and environmental conditions including temperature, humidity, exposure to light, and barometric pressure– and the ability to collaborate and share that information with your business partners.

SCiAN - a science-technology based contract clinical research company (CRO) - provides e-clinical and EDC solutions and clinical data management systems and services to the healthcare industry for IND stage (phases II - III) clinical trials.

Since 1941, the people of Southern Research have contributed to scientific advancements leading to life-saving drugs, safer space exploration, cleaner air and energy production, and enhanced national defense. Southern Research is a not-for-profit, 501(c)(3) organization conducting basic and applied research in Alabama, Maryland, and North Carolina in the areas of drug discovery, preclinical drug development, advanced engineering, and environmental protection.

Spaulding Clinical Research, LLC (www.spauldingclinical.com) provides Clinical Pharmacology, Cardiac Core Lab clinical research services, and is a medical device manufacturer. Spaulding Clinical operates a 155-bed clinical pharmacology unit with 96-beds of telemetry in West Bend, Wisconsin, USA. The facility is paperless, with a Phase I Electronic Data Capture system and bi-directional interfaces to safety lab, bedside devices and telemetry. As a Phase I-IV Core ECG Laboratory provider, Spaulding Clinical offers the complete suite of equipment provisioning and electrocardiograph over-reading services with state-of-the-art technologies, including the proprietary Spaulding Model 1000iQ Electrocardiograph, expert cardiologists and project managers.

Swiftwater Group was founded in 1998 by a small group of seasoned pharmaceutical consultants and industry veterans with the express purpose of taking a fresh approach to helping clients succeed. Our vision was – and remains today – to approach each client problem, challenge, or opportunity with customized, industry-specific solutions delivered by true life sciences experts.

Synergy Research Group (SynRG™) is a leading Russian Contract Research Organization (CRO) successfully assisting pharmaceutical and biotechnology companies, as well as global CROs in conducting clinical trials in Russia and the Commonwealth of Independent States (CIS) since 2002.

SynRG was established as an answer to the growing demand for clinical trials in Eastern Europe. We are committed to provide high quality services capitalizing on our in-depth knowledge of international and local regulations, long-term relationships with central and peripheral medical institutions, and a broad network of investigators with vast clinical research experience in various therapeutic areas.

Terso Solutions is a leading provider of automated inventory management solutions for tracking high-value medical and scientific products in healthcare and laboratory supply chains. Backed by 13 years of RFID product development and implementation experience, our commercially proven, field tested solution has logged over 9,000,000 operational hours around the world. With no hardware to purchase and no software to install, our integrated RFID solutions can help eliminate manual processes, improve regulatory compliance, and reduce stock-outs and expired products.

Xait provides global web-based database solutions. Xait is the company behind XaitPorter, an application with a proven track record with many large and smaller companies world-wide. Xait has four out of the top 10 Forbes companies as clients, and have global framework agreements with several global corporations for XaitPorter.

Partnering with a specialist for early drug development can significantly reduce product risk and accelerate development timelines. Since 1997, Xcelience has been renowned for reliably expediting drug development and reducing compound risk. Our scientists have considerable experience overcoming challenging physical and chemical properties in a manner that results in improved solubility and compound bioavailability. Our outstanding quality record, development expertise, disciplined project management and willingness to customize enables us to deliver real advantage to pharmaceutical innovators focused on small molecule development.