2017 Exhibitors & Experience Partners


2017 Premier Exhibitors


An SCRS Global Impact Partner™
Acurian is a leading full-service provider of clinical trial patient enrollment and retention solutions for the life sciences industry. The company increases the enrollment performance of investigator sites worldwide by identifying, contacting, prescreening, and referring people who live in the local community but are unknown to a research site. As a result, trial sponsors complete enrollment without incurring the unexpected expense of adding sites, time, or CRO change orders. Acurian’s investors include Euclid SR Partners, ProQuest Investments, JP Morgan Partners, Flatiron Partners, CDP Capital Technology Ventures, and Merck Capital Ventures. www.acurian.com

An SCRS Global Impact Partner™
Bioclinica is a specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process so sponsors can see key details, uncover hidden insights, and make better decisions. Bioclinica is organized by three business segments and serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia. Representatives from Financial Lifecycle Solutions, Research Network and Patient Recruitment-Retention divisions will be available to meet, review your requirements and discuss opportunities to partner. www.bioclinica.com

ClinEdge and BTC Network provide a full range of clinical and outsourced business services to clinical research sites, pharmaceutical companies, and CROs. Together, the two companies represent four business segments: two global networks of research clinics with over 1,000 physician investigators, site financial management, and patient recruitment/retention. Recruitment and retention services include, but are not limited to, online engagement and advertising, a national patient database, patient travel concierge, national and local advocacy, and an in-house call center. With extensive experience across over 300 different medical indications representing all therapeutic areas, the ClinEdge and BTC Network teams have helped to successfully conduct thousands of clinical studies over the last several years. Come by and talk to one of our representatives to see what we have been up to! If you are too busy to see us you can also drop Christian Burns an email at Christian@clin-edge.com or visit www.clin-edge.com or www.btcsites.com. Don’t forget to come to SCRS’s best party on Friday night!

An SCRS Global Impact Partner™
Clinical Conductor is the industry’s first collaborative and configurable CTMS for research managing or executing clinical trials. The system and provides users with the specific features and functionality they need to recruit effectively, improve overall patient visit satisfaction maintain billing and research compliance and maximize profitability. Used by over 1,800 organizations around the world, Clinical Conductor provides organizations with the tools they need to continue to raise the bar in clinical research. www.bio-optronics.com

Clinical Research IO (CRIO) is an e-source and site workflow solution for investigators. Customize source templates and use a tablet to capture data quickly and accurately. Our system is a revolutionary new way of performing clinical research.

Complion is a flexible, enterprise-wide platform that enables clinical research sites to centralize and process regulatory documents across their organization. Built by clinical researchers for clinical researchers, Complion removes walls between physicians, administrators and staff by intelligently providing secure access to the right document when they need it. Leading sites, hospitals, academic medical centers, health systems and cancer centers around the country use Complion to save money, improve compliance, and streamline operations.

CSSi is a Site Performance Company. Our services focus on managing the clinical trial enrollment process and supporting sites to maximize their performance in meeting or exceeding patient accrual timelines. We work with each site individually to ensure that all efforts are specific to each site’s geography, staff availability, past experience and suggestions for the particular study. CSSi utilizes a highly talented in-house staff to deliver these services which allows us to meet your enrollment goals while being mindful of your study budget. We believe that setting each site up for success is best achieved by investing our efforts in developing site-specific enrollment strategies which minimizes costs and maximizes the sponsor’s return on investment. For more information regarding CSSi’s targeted enrollment services and capabilities please contact Chris Trizna, or visit the CSSi website, www.CSSienroll.com.

Devana Solutions is dedicated to providing revolutionary software that automates the tracking of clinical trial study leads, contacts and performance metrics allowing research sites to win more studies. Devana is the first cloud-based sales solution built exclusively for research sites by research professionals. www.devanasolutions.com

An SCRS Global Impact Partner™
goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the pharmaceutical, biotechnology, and medical device industries. We have partnered with more than half of the top 20 pharma and 5 of the top 10 CROs in study startup, including: Novartis, Genentech Roche, ICON, INC Research, and Covance. Visit us at www.gobalto.com.

An SCRS Global Impact Partner™
Greenphire’s technology solutions take a patient-centric and site-centric approach to driving data integrity and data completeness for sponsor, CRO, and site clients. Greenphire’s patient payment and communication system, the ClinCard System, is designed to improve the clinical experience for patients and sites, drive positive patient behavior, and increase patient retention and compliance. The ClinCard System also significantly reduces site and study team administration associated with patient payments and communication, enabling coordinators and study managers to focus time on ensuring data cleanliness and completeness. For more information, please visit www.greenphire.com.

Hylant Group

Hylant Group’s Life Science Practice has expertise in tailoring insurance and risk management programs that respond to the changing exposures Life Science organizations face everyday. Hylant advises and consults with organizations in the Clinical Research, Medical Device, Pharmaceutical, and Clinical Trial industries. In this complex and ever changing environment, it’s important to trust an advisor who understands the industry and your business goals while delivering a program that reduces operating costs, improves efficiencies, while protecting assets and reputations. For more information please contact Michael Yon at 513-354-1612. www.hylant.com

An SCRS Circle of Innovation™ Partner
INC Research/inVentiv Health (Nasdaq:INCR) 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 address new market realities where clinical and commercial share expertise, data and insights to accelerate biopharmaceutical performance. With more than 22,000 employees and the ability to support customers in more than 110 countries, our global scale and deep therapeutic alignment enables INC Research/inVentiv Health to help customers successfully navigate an increasingly complex environment. For more information on our Raleigh, N.C.-based company, visit www.incresearch.com or inventivhealth.com.

An SCRS Site Voice™ Partner
An SCRS Global Impact Partner™
Medidata Solutions is the leading global provider of cloud-based solutions for clinical research in life sciences. We are committed to advancing the competitive and scientific goals of global customers, which include over 90% of the top 25 global pharmaceutical companies; innovative biotech, diagnostic and device firms; leading academic medical centers; and CROs.


Medix Clinical Research offers workforce solutions and consulting services for sites, sponsors and CROs. Our in-house clinical research expertise will help you enhance operational strategy, maximize financial efficiency and bolster your talent pipeline

MedPoint Digital

MedPoint Digital develops specialty eClinical platforms for investigator portals, virtual investigator meetings and monitor remote site visits. Our digital solutions enable sites to be more productive, with study eBinders, site message centers, eClinical sign-on centers, online study training and site dashboards. All systems are ICH-GCP compliant and designed to be user-friendly.

An SCRS Global Impact Partner™
PRA Health Sciences is one of the world's leading global contract research organizations (CRO), providing outsourced clinical development services to the biotechnology and pharmaceutical industries. At PRA, providing innovative solutions for our clients is what we do. Side-by-side with our clients, we strive to move drug discovery forward, helping them to develop life-saving and life-improving drugs. PRA has more than 11,000 employees working in 80+ countries providing comprehensive clinical development services across all phases. From full service clinical development to the pioneering Embedded Solutions™ model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. PRA has worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 50+ such drugs. www.prahs.com

Quorum Review IRB is a privately-held, independent ethics review board fully accredited by AAHRPP. Our mission is to safeguard the rights and well-being of research participants. With 15 board meetings a week, we provide sponsors, CROs, institutions and sites with reliable, responsive service to support efficient study start-up and management.

RealTime-CTMS, the newest Clinical Trial Management System for investigative sites. Unlimited users, unlimited locations, unmatched user-friendliness and workflow management. We also offer website development and true website integration for study listings. If you are looking for a great new CTMS system or need to make a change, we can help. Please contact Rick Greenfield at (210) 386-4201 or visit our website at www.realtime-ctms.com

Synexus is the world’s leading SMO and operates a network of 27 dedicated research and 68 affiliated sites. All Synexus sites are fully staffed by GCP trained investigators, supported by patient engagement, project management and medical teams. Synexus is dedicated to trial excellence across cardiovascular, metabolic, musculoskeletal, respiratory and CNS diseases.

An SCRS Global Impact Partner™
Veeva Systems Inc. is a leader in cloud-based software for the global life sciences industry. Committed to streamlining the end-to-end clinical trial process, Veeva offers the industry’s first cloud platform that combines EDC, eSource, CTMS, eTMF, and study start-up to unify clinical data management and clinical operations. Veeva has more than 500 customers, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

VitaLink Research is wholly owned and dedicated solely to clinical research networks that connects researchers, doctors, and patients with the shared goal of bettering research across the industry - all in one place. We are a true “one stop shop” for high quality research and results. Each of our research facilities focuses solely on conducting clinical trials and collecting the most accurate data possible. Research should never be an afterthought. At VitaLink, it’s the priority.

2017 Performance Exhibitors

ACRP is a non-profit organization representing and supporting clinical research professionals from diverse organizations. Since 1976, ACRP has promoted excellence in clinical research through exceptional certification, professional development and membership programs. With members in over 70 countries, ACRP takes a global approach to pursuing ethical, responsibly and professional clinical research.www.acrpnet.org/.

The Alliance for Multispecialty Research, LLC is a nationwide company of 17 Clinical Research locations recognized as among the most experienced in the industry. AMR acknowledges the importance of multi-site coordination using our standardized processes. This allows us to maximize economies of scale and consistency in order to exceed Sponsor goals ahead of schedule and under budget.

Don’t forget to stop by booth 514 to demo ACS360—the world’s most affordable and comprehensive eSource solution. From paperless eSource data capture to electronic budget management, site recruitment and regulatory document management solutions, ACS360 is built for site efficiency. See why more sites prefer paperless studies with ACS360.

Antidote powers the clinical trial matching engine for more than 120 of the biggest patient organizations and health portals such as JDRF, Lung Cancer Alliance, Healthline, and many more. We run clinical trial notification services reaching millions of highly-engaged patients every month. Tap into our unique network and start connecting with patients in your area. Visit antidote.me/base.

BRANY is a clinical trials service provider, offering an array of comprehensive and efficient support services to Sponsors/CROs, Institutions, Hospitals and Private Sites conducting research. Over the past 15 years, BRANY has worked diligently to develop a strong infrastructure of services that support researchers and organizations in their pursuit to conduct quality research. BRANY’s unique model offers Local/Central IRB, Study/Site Identification, Contract and Budget Negotiations, Clinical Trial Coverage Analysis, Research Education, Research Compliance and Consulting services. www.brany.com.

Fully automated clinical trials and site management solution. Electronic source, drug accountability, and more. Created by experienced PI and proven in 300 clinical trials, 8 successful FDA inspections, and 11,000 patients. Intuitive Cloud application accessible from everywhere and on any device. Transform your site to paperless painlessly and reap huge benefits from this complete system that manages your trials from set-up to archive. Extensive demo's will be available. In the meantime, you can call 210.614.4800 for a demo and information!

Whether you’re a physician’s practice or community hospital, the innovative, flexible solutions from Chesapeake IRB help connect your people, processes, and information to deliver real impact and minimize risks. We can empower you to excel through our highly supportive and collaborative approach, and strategic use of effective technology.

An SCRS Global Impact Partner™
Clincierge® improves clinical trial performance by reducing barriers to participation, enhancing enrollment, and minimizing drop-outs. Our expertise and services lessen burdens on patients, caregivers, and sites while improving communications and coordination. We help keep studies on schedule, on budget, and data quality high, while making patient concerns a priority.

An SCRS Global Impact Partner™
Clinical Ink is an innovation-driven eSource solutions company dedicated to delivering technology that makes clinical research easier for sites, sponsors, subjects and regulators. Developers of SureSource, the first purpose-built electronic source record (ESR) that provides cleaner data more quickly, Clinical Ink is dedicated to eliminating paper documentation in clinical research. For more information, please visit: www.clinicalink.com

At Clinical Trials of South Carolina, our mission is to safely advance science and improve lives through quality-driven research, collaboration and innovation. Our team of dedicated recruiters, coordinators and research assistants lead us to conduct top-level research studies across multiple therapeutic areas.

Clinithink was founded in 2009 to give life sciences organizations and healthcare providers access to valuable unstructured clinical data. Clinithink’s market leading clinical natural language processing (CNLP) software solution is used to solve important business problems in clinical research, population health, and predictive analytics. The automation of pre-screening to dramatically accelerate patient recruitment in clinical trials is a strong focus, delivering unique benefits to sponsors and research sites alike.

An SCRS Global Impact Partner™
DrugDev’s mission is to simplify life at the clinical trial site through technology. In this way DrugDev enables sponsors, CROs and investigators to do more trials together. Featuring the largest global network of active investigators, the industry’s leading grant payment and site contracting system in CFS Clinical (www.cfsclinical.com), and the award-winning TrialNetworks (www.trialnetworks.com) platform of clinical operations apps, DrugDev creates and drives standards which promote collaboration, improve quality, shorten timelines and reduce cost. In addition, DrugDev provides Hosted Data Solutions for clinical trials including hosting the Investigator Databank (www.investigatordatabank.org) for Novartis, Janssen, Merck, Lilly and Pfizer. Learn more at www.drugdev.org.

Elligo’s comprehensive suite of services, tools and technologies streamline patient identification and qualification, site activation, patient enrollment, study initiation and study conclusion. Not only does this result in more efficient and cost-effective trials, but patients gain access to new treatment options, physicians avoid the cost and effort of building and managing in-house clinical research infrastructure and sponsors bring new therapies to market faster.

GlobalCare Clinical Trials, LLC is the leading global provider of ambulant healthcare services for clinical trials. GlobalCare provides innovative, GCP-compliant services for biopharmaceutical companies by conducting selected study visits at locations convenient and comfortable for the patient when travel to the investigator site is not practical. GlobalCare’s traveling clinicians provide patients with a convenient way to participate in trials regardless of study duration, frequency of visits, their disease state or distance to the study site. Additionally, GlobalCare’s patient-centric approach helps to accelerate patient recruitment and improve study patient compliance and retention.
Website: http://www.globalcarect.com/


An SCRS Global Impact Partner™
With more than 500,000 registered members, growing at an average of 6,000-10,000 new registrants per month, HealthCarePoint has become one of the fastest growing networks in healthcare and clinical research and is poised to save the industry (Sponsors, CROs, Investigator Sites, IRBs, and Regulatory Agencies among others) billions of dollars in time and resources.

For more information visit www.healthcarepoint.com


ImageBloom is a full service advertising agency that specializes in helping sites and sponsors improve their enrollment capabilities for clinical studies of all kinds. There is no one-size-fits-all approach, so our professionals with years of research experience will develop a plan for success on a local or global level.


Insearch is a clinical business development company dedicated to study identification and the site selection process. Our exclusive network provides sponsors and CROs with experienced and successful clinical research sites located throughout the US. The network consists of 22 research groups, 65 site locations and 200 investigators. The size of our network grants us a unique perspective to understand the capabilities of each PI and site which allows us to match sponsor/CRO studies with sites that have the correct combination of PI, staff, facility and access to qualified, committed research subjects. If you are a site that needs personal and productive business development or a sponsor/CRO that needs investigators that fit your studies, please come visit our booth. We are also available via our website www.insearchgroup.net or direct contact with Chris Heironimus (727) 544-4842, chris@insearchgroup.net.


An SCRS Global Impact Partner™
IntegReview IRB provides ethical review for pharma, device and biotech companies in the U.S., Latin America and Canada. Daily meetings. Customer Support 24/7 with 24-48 hour document turnaround. Online document management system. Consulting services. Quality-driven. Responsive, experienced and flexible while maintaining ethical integrity. Fully accredited AAHRPP. Woman-owned since 1999. www.integreview.com.

Interspond, LLC is a Trial Management Organization (TMO) established in 2003 that works with a network of exclusive and affiliated, multi-therapeutic sites across the country. As such we seek to identify study opportunities for the sites with which we work. Once identified, we query the sites, submit them for consideration for participation, facilitate the study start-up process, and negotiate the contract and budget. Recently, Interspond signed an agreement to provide exclusive business development services to a network of neurology/rheumatology/ophthalmology sites. As a result, Interspond has a hybrid model working with sites on an exclusive and non-exclusive (affiliated) basis. We take pride in the long standing established relationships we have with many sites and delight in our outstanding reputation in the industry.

MCSP was established based on the needs and demands of clinical research site professionals across the country. We have a network of research sites who share centralized processes, training, contracts, and budgets. Our sites specialize in Respiratory Research, Sleep Medicine, Gastroenterology, Pediatrics, Internal Medicine, Endocrinology, Rheumatology, Allergy, and CNS. We have also developed preferred partnerships with Sponsors and CRO's. We are members of The Society for Clinical Research Sites (SCRS), because as sites we deserve to have a unified voice before our partners, regulators, and industry stakeholders.

An SCRS Global Impact Partner™
With headquarters in the US and UK, Myoderm is a global leader in the sourcing, distribution, and management of pharmaceutical products and supplies for clinical trials, including biosimilar research. With an extensive network of qualified manufacturers and suppliers, they specialize in accessing medications in all therapeutic classes and dosage forms – even the most difficult to obtain. Through their deep expertise, innovative approach, and commitment to personalized service, Myoderm provides the optimal supply solution for clients around the world. Visit www.myoderm.com

Outcome Health delivers better health outcomes and positively impacts the human condition through decision technology. Founded in 2006 by Rishi Shah and Shradha Agarwal, the company has doubled each year in its scale of business partnerships with global life sciences and medical device companies, product innovation, team growth and technology implementation, with a presence in 20% of the outpatient facilities in the United States. Its decision technologies such as digital anatomy boards, interactive educational tablets and mobile connectivity in consultation rooms deliver measurable patient outcomes through actionable intelligence on conditions, treatments, and lifestyle changes to improve the quality of life. To find out more about Outcome Health, visit www.outcomehealth.com.

The Patient Recruiting Agency (TM) (TPRA) is a full service patient recruiting and retention organization supporting Sponsors, CROs, SMOs and Investigators in Canada and the United States since 1999. TPRA has been incorporated in Canada since 2004 and began recruiting patients in 1999. Since that time, TPRA has completed over 2,200 clinical trial campaigns for over 150 indications. Services include study branding, traditional and online media production and placement, study-specific websites, patient phone screening and RADIUS365TM, TPRA's online platform for tracking and managing all response, referral, randomization and retention activities in real-time. One of TPRA's specialties is the production and placement of customized direct-to-patient advertising and technological solutions specifically for clinical trials. The unique characteristic that sets TPRA apart from other competitors is that all services are performed by TPRA's own IN-HOUSE staff with no outsourcing which offers its clients greater flexibility, accountability and cost-efficiencies than those offered by other competitors. For more information about TPRA services and capabilities please contact Corrie Palm, or visit TPRA’s website, www.PatientRecruiting.com.

PharmaSeek Companies

The PharmaSeek Companies are dedicated to helping sites improve the management of their research operations. Our seasoned professionals provide turn-key business solutions, which allow site personnel more time to focus on clinical activities. These outsource business solutions include Patient Recruitment, Medicare Coverage Analysis, Receivables Management, Short-term Study Financing, Budget Negotiation, and Contract Negotiation. To find out more about our services, please contact Ted Fuertges at (608) 664-9000 ext. 2231 or visit our website at www.pharmaseekcompanies.com.

An SCRS Global Impact Partner™
PPD is a leading global contract research organization providing drug discovery, development, lifecycle management and laboratory services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 46 countries and more than 13,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

Radiant Research is the country’s largest WHOLLY OWNED network of clinical trial sites with fully integrated quality systems and a database of over 2.5 million research participants. With over 75 research sites and more than 100 Principal Investigators, Radiant has conducted more than 14,000 multi-therapeutic Phase I-IV studies.

The platform developed by Research Hive shortens the development timeline for investigational treatments. Research Hive helps physicians efficiently and effectively identify patients and communicate with their team about potential research subjects, among other things. Improving Physician confidence in their enrolling protocols is one of the most effective ways to improve their team’s enrollment rate.

SentralBinders is a new electronic source and Investigator Site File system that has the benefits of paper without the need for printing and storage. Collect data quickly and efficiently with a system that works the way you do. Mark it up, file it, have it viewable by all and then come back later to make necessary corrections. Have all of your study documents available to everyone at all times.

Splash Clinical, a wholly owned subsidiary of Teuteberg, Inc., is a global marketing services company specializing in Online and Social Media Marketing for Clinical Trial Patient Recruitment. We combine our extensive knowledge of online and social media marketing with rich analytics to create highly targeted campaigns that reduce the time and expense required to recruit patients. You can trust that our quality, knowledge, and customer service will help your clinical trial succeed.

SRI’s Clinical Trial Unit: Phase 1–3 expertise; 13-bed/three infusion-chair facility; 24-hour medical monitoring, onsite physician availability; high caliber physician network supported by professional staff, numerous therapeutic specialties; extensive patient databases; Neurology and Orthopedic Pain Management experience.

Backed by decades of experience in innovative solutions to meet clients’ needs. sri.com/biosciences

Website connecting patients to clinical trials through thousands of social media communities across Instagram, Snapchat, Facebook, Twitter, and Pinterest. Live in 24 hours, sites receive 30-200* patients every 30 days. Sites can maximize enrollment with Tools including: StudyKIK Patient Messaging Suite (Instant Text Messaging, Appointment Reminders, & Text Blasting).

SubjectWell is the first risk-free clinical trials marketplace for patient recruitment. SubjectWell accelerates enrollment by engaging the 96% of Americans who have never participated in a clinical trial. And trial sites only pay for patients who randomize.

Investigator payments and site contracting have long been a thorn in the side of sites, sponsors and CROs. Led by industry pioneers in this space and motivated by promoting site sustainability and trial efficiency, the experts of Transcend Trials invite you to join them in driving change by leveraging their technology-enabled services powered by Medidata Payments.


ThreeWire is a global patient recruitment, enrollment, retention and management provider for the pharmaceutical, biotech and medical device industries. Our proven, customized, centralized and site-based service offerings provide valuable solutions and measurable outcomes for sponsors, CROs, sites and patients in North America, Europe, the Middle East and Latin America.

Total Clinical Trial Management (TCTM), is a contract research organization based in Dallas, Texas. TCTM has a unique perspective on emphasizing the relationship with the clinical research site as a primary driver for successful clinical trial completion. TCTM has a wide range of therapeutic expertise with recent areas of focus including pain, orthopedic injury, GI, dermatology, cosmetics, over-the-counter (OTC) and generics studies.

Founded in 2013, Trial Connections locates clinical trial opportunities for investigator sites across all therapeutic areas and phases. We offer cost effective business development services to help sites build their pipeline of study opportunities and grow their business. www.trialconnections.com

Trialspark is a digital health company that accelerates patient recruitment for clinical trials. Trialspark applies machine-learning to data aggregated from social media, online searches, and health websites to engage the exact patient groups needed based on study criteria. We’ve boosted recruitment rates by over 2X while also helping our clients track recruitment metrics in real-time with our software.

Woodley Equipment Company is a specialist global medical equipment supplier to the Clinical Trials Industry, with unrivalled levels of customer service and an extensive range of Laboratory and Medical Equipment, Kitting Service, Consumables, and Point of Care Systems for rental and purchase. www.woodleyequipment.us


2017 Alliance Sponsor

SignalPath's site-focused eResearch platform is designed to streamline the operational workflow of patient management and protocol management, including finance and start-up modules to optimize site outcomes. Our Enterprise Network Manager then enables management support for, and analytics of performance across, site networks utilizing the SignalPath eResearch platform.

2017 Site Solutions Summit Media Partners

PharmaVOICE magazine provides commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.

Founded in 1994, CenterWatch is a trusted source and global destination for clinical trials information for both professionals and patients. Located in Boston, CenterWatch provides proprietary data and information analysis on clinical trials through a variety of newsletters, books, databases, and information services used by pharmaceutical and biotechnology companies, CROs, SMOs, and investigative sites involved in the management and conduct of clinical trials.