Company Press Release

, an agency for eClinical teams, has provided this infographic that categorizes more than 190 companies in this space by their focus.

Articles

Bracken Marketing has provided this infographic that categorizes more than 190 companies in this space by their focus.

A Visual for the eClinical Landscape

Clinical trial costs have surged over the past decade, with recent reports stating that from 2008 to 2013, the average cost per patient increased by $23,600, or by 157%. A major contributor to the cost of a clinical trial is subject recruitment and the associated staff costs.	 	So, examining every opportunity to reduce the sample size for a study is an important and necessary step in drug development.	 	Reducing sample size without losing power can be accomplished by one of three principles. In this infographic, Statsols examines these and present 15 ways researchers can reduce sample size in clinical trials.	 	Check out the infographic 

Ways to Reduce Sample Size In Clinical Trials

	PAREXEL Advances Patient-Centric Drug Development with Introduction of its Patient Innovation Center

 – PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access.  With a patient-centric approach, the Center can help sponsors improve the drug development process by reducing the practical, financial and geographical barriers patients and caregivers often face, and optimize patient involvement and engagement.

	Simplifying the patient journey with a focus on the patient’s needs and experience has been proven to enhance the drug development and commercialization process.  A 

 recently released by The Economist Intelligence Unit (EIU) and commissioned by PAREXEL found that patient-centric trials took almost half the time to recruit participants and that drugs developed using these approaches were 19 percent more likely to be launched.  However, patient-centric designs were only utilized in 5.2 percent of Phase II and III trials across the industry. In the commercialization phase, a patient-centric approach can enhance the process as well.  With the Patient Innovation Center, PAREXEL will help facilitate sponsors’ ability to develop comprehensive strategies for patient-centric drug development and commercialization and leverage new approaches including Patient-Centric 

, virtual (or at-home) trials and direct-with-patient studies.

	“While the evidence is clear that patient-centric approaches can improve the development process, many sponsors remain in need of a roadmap to effectively apply these strategies over time,” said Sy Pretorius, M.D., Senior Vice President, Medical & Scientific Services, PAREXEL.  “At PAREXEL we are committed to designing trials with patients in mind.  Through the Patient Innovation Center, we aim to bring the full breadth of our services, expertise and innovation to clients to help more-effectively implement these approaches, reducing the barriers and optimizing patient involvement throughout the drug development and commercialization journey.”
	
	PAREXEL’s Patient Innovation Center services include:

 PAREXEL’s Patient-Centric Protocol Optimization service proactively involves patients and PAREXEL Site Alliance expert nurses in the protocol-design process to identify and address potential practical challenges to study participation. By maintaining focus on patients’ needs and augmenting the feasibility process, patient burden can be reduced and the experience for participants optimized.  By using a combination of web listening, patient, caregiver and site staff input, PAREXEL can help sponsors positively impact study recruitment and retention.

: PAREXEL’s patient-centric focus can help ensure a pragmatic approach to study implementation to reduce patient burden, including the deployment of virtual trials.  It includes elements such as online recruitment, eConsent, home nursing, direct-to-patient drug shipments, patient apps and video dosing to enhance patient experience and compliance.  PAREXEL’s 

 service is focused on continuous data collection through the use of wearables to remotely capture, transmit and store data in a secure platform powered by PAREXEL’s Perceptive

 Cloud.  Deployment of the virtual trials service brings the research to patients and their caregivers, reducing the practical, financial and geographical barriers to clinical study participation for patients and their families.

: PAREXEL’s commitment to encompassing the patient’s needs and experience extends throughout the product development lifecycle – and is critically focused on ensuring patient access to important therapies.  In preparing for and supporting product commercialization, PAREXEL aims to deliver research that reflects patients’ true care path and experience – and that will ultimately support the key clinician, payer, and regulatory decisions that will drive patient access.  PAREXEL’s approach leverages technologies and processes to collect patient-specific data via mobile sensors and applications, patient-reported outcomes surveys, direct-to-patient studies and other strategies – all informed by a deep understanding of the patient care path, and the market’s clinical and payer evidence requirements.

	“In today’s drug development landscape, it is more important than ever that we as an industry place the patient’s needs at the core of everything we do,” said Peyton Howell, Chief Commercial and Strategy Officer, PAREXEL.  “At PAREXEL, we understand how critical patient involvement and engagement are to successful clinical development and, ultimately, access to therapies.  As we look to the future, we will continue to seek new ways to optimize the patient experience as we partner with our clients to develop and deliver important new medicines.”

	For more information about PAREXEL visit 


	
	PAREXEL International Corporation is a leading innovator of global biopharmaceutical services.  We simplify our clients’ journey of transforming scientific discoveries into new medical treatments for patients with high-quality Phase I-IV clinical research, regulatory, consulting and market access services.  PAREXEL develops breakthrough innovations and solutions by leveraging its comprehensive therapeutic, technical and functional expertise, in more than 100 countries around the world. For more information, visit 

	PAREXEL is a registered trademark of PAREXEL International Corporation. All other trademarks are the property of their respective owners.

Parexel Patient Centric DD PR

	Clinerion and Semicrol integrate Patient Network Explorer and Fundanet CTMS to enable end-to-end clinical trial management.
	 
	Clinerion and Semicrol announce a collaboration which will integrate the functionality of Clinerion’s Patient Network Explorer with Semicrol’s Fundanet CTMS. The partnership will integrate patient data throughout the clinical trial process, from planning to reporting of results.
	 
	The technical and commercial collaboration between the two companies will integrate the functionality of Clinerion’s Patient Network Explorer with Semicrol’s Fundanet Clinical Trials Management System (CTMS), enabling the automated, efficient sharing of patient data from a hospital’s electronic health records system to the CTMS running a clinical trial at that hospital.
	 
	The collaboration will give clinical trial sponsors and managers unified tools to manage trial data and workflows throughout the clinical trial process, from planning to reporting of results. This will enable a broader approach in clinical trials, drug development support and better outcomes for patients. Patient data privacy is preserved, and patient data remains within the hospital IT infrastructure throughout.
	 
	Fundanet CTMS is a world-class clinical trial management system designed to provide quick and easy access to study or subject information utilizing simple and intuitive navigation. Patient Network Explorer aggregates patient insights from anonymized patient records throughout Clinerion’s global network of partner hospitals to provide services for clinical trial protocol feasibility, site selection, and patient search and identification, as well as generating real-world data for medical access applications.
	 
	“We have seen a significant shift in recent years in the complexity of clinical research recruitment processes and the amount of time needed to identify eligible patients to be successful in the clinical trial enrollment,” said Vicente Alciturri, International Director of Semicrol. “In order to meet the changing needs of the research marketplace, we sought out a partner who shared the same core values as us for helping researchers conduct the best possible research and improve operations. We found that partner in Clinerion. The technology flexibility and years of experience makes Clinerion an ideal fit for Fundanet CTMS and an exciting new offering for the clinical research Institutes, CROs and pharma industry as a whole in Spain, Portugal and Latin America. This integrated solution will allow users to reduce redundancy, obtain directly access to high-quality data, and make decisions faster. We look forward to a great partnership.”
	 
	“Semicrol is one of the innovative market players in the world of software solutions for the clinical research and we are pleased to partner with them in bringing a joint offer to hospitals and trial sites,” says Ian Rentsch, CEO of Clinerion. The complementarity of Patient Network Explorer and Fundanet CTMS creates a combined service which offers more than the sum of its parts.”
	 
	Semicrol and Clinerion will present their collaboration for the first time at the BIOSPAIN Congress at Seville, Spain, on September 25th-27th, 2018.
	 
	About Clinerion
	 
	Clinerion accelerates clinical research and medical access to treatments for patients. We use proprietary technologies for analysis of patient data from our global network of partner hospitals. Clinerion's Patient Network Explorer radically improves the efficiency and effectiveness of clinical trial recruitment by offering data-driven protocol optimization, site feasibility evaluation and real-time patient search and identification to match patients to treatments. Our technology solution provides real-world evidence analytics for medical access. Clinerion facilitates the participation of partner hospitals in leading-edge, industry-sponsored trials and time savings in patient recruitment. We create innovative and disruptive fit-for-purpose solutions which enable pharmaceutical companies to shorten patient recruitment and save costs by streamlining operations and leveraging strategic intelligence. Clinerion’s proprietary Big Data analytics technologies leverage real-time data from electronic health records which comply with international patient privacy and data security regulations. Clinerion is a global data technology service company headquartered in Switzerland.
	Clinerion website: www.clinerion.com
	Clinerion’s Patient Network Explorer: www.clinerion.com/index/OverviewOurSolutions/ClinerionPatientNetworkExplorer
	 
	For more information, please contact:
	Le Vin Chin
	Director, Head of Marketing and Communications
	Clinerion Ltd
	Margarethenstrasse 47, CH-4053 Basel, Switzerland
	Tel.: +41 61 865 60 54
	media@clinerion.com
	 
	About Semicrol SL
	 
	Semicrol, the creator of Fundanet CTMS, is a leader in cloud-based software solutions for the clinical research industry and is dedicated to solving problems and providing systems that make the research process more efficient and more profitable throughout the software framework.
	Fundanet CTMS is a world-class clinical trial management system designed to provide quick and easy access to study or subject information utilizing simple and intuitive navigation.
	Semicrol Headquarter is based in Santander (Spain) and has local offices in Mexico and Bogotá (Colombia) for the LATAM region. Established in 1979, Semicrol comprises around 70 people devoted to consultancy, software development, implanting and maintaining information systems and applications for Hospitals, Research Institutes, Universities, Pharma companies, CROs and medical devices companies.
	Semicrol’s website: www.semicrol.es
	Semicrol’s Fundanet Suite: www.fundanet.es
	 
	For more information, please contact:
	Vicente Alciturri Fernández
	International Director
	SEMICROL S.L.
	C/ Isabel Torres, 7, 39011 Santander, Cantabria, Spain
	Tel.: +34 942 314 224
	vicente.alciturri.fernandez@semicrol.com
	 

Clinerion Semicrol PR

Dublin, Ireland, 10 September, 2015 – ICON plc, (NASDAQ: ICLR) 

a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, today announced that it is working with IBM (NYSE: IBM) to help reduce the time and costs of drug development, while also offering patients enhanced quality of care by connecting them to relevant clinical trials. ICON will tap Watson's cognitive computing power to help automate the cumbersome process of identifying patients who meet the criteria for a clinical trial, and to analyze protocols to assess trial feasibility and identify optimal trial sites.

 to its breast, lung, colon and rectal cancer trials. The solution enables ICON to advise sponsors how many patients match their trial criteria, where they are located and how they will recruit them. 

 will facilitate access to de-identified patient data, including 50 million patient records contained in the data set from Explorys, which IBM acquired in April. At the same time, ICON enhances IBM Watson’s capabilities by providing expertise into clinical trial protocols and clinical operations.

	The cost and time involved in clinical trials is considerable. More than $1.3B is spent on patient recruitment by drug developers each year and yet fewer than 5% of cancer patients participate in a clinical trial. It also typically takes 6-12 months to start up a global phase III drug trial and another 12 months to enroll the required number of patients.

	Commenting on the announcement, ICON’s Chief Operating Officer, Dr. Steve Cutler, said: “Recruiting the required number of patients for clinical trials is a constant challenge for our customers and can represent more than 30% of total study costs. By applying IBM Watson to our clinical trials, we have the potential to revolutionize clinical trial feasibility, patient recruitment and study start-up timelines which will help our customers take significant time and cost from their development programs. Together with IBM, we are also providing a better and faster way to connect patients with clinical trials that are most relevant to them. Today’s announcement is an excellent example of disruptive innovation and represents ICON and IBM’s shared vision for using industry-leading technologies and real-word data sets to improve clinical development.”

	“Clinical trials are crucial in the drug and treatment development process, but when it comes to identifying appropriate trial candidates, there are significant data challenges, which can contribute to delays for bringing new therapies to market,” said Sean Hogan, Vice President and General Manager, IBM Healthcare. “Through cognitive computing and cloud-based data, our goal is to help our clients accelerate the time it takes to complete clinical trials and reach conclusive trial results.”

ICON and IBM to Revolutionize Clinical Trial Feasibility, Patient Recruitment and Study Start-up Timelines

PRINCETON, NJ and DURHAM, NC – Sept. 10, 2015

 – Certara®, the global biosimulation technology-enabled drug development company, and Paidion Research, Inc., a pediatric clinical research organization (CRO), today announced a new partnership dedicated to promoting more efficient and reliable drug development for pediatric patients. The partnership harnesses Certara’s unmatched biosimulation (modeling and simulation) and regulatory writing capabilities, with Paidion’s regulatory strategy and pediatric clinical trial management expertise to address the critical challenges of bringing new therapies to children.

	 “The US Food and Drug Administration (FDA) reports that pediatric product development initiatives have resulted in improved product labeling, increased identification of adverse events, and the development of new pediatric formulations. However, 42 percent of recent pediatric trials have failed to establish either safety or efficacy,” said Certara Chief Executive Officer (CEO) Edmundo Muniz, MD, PhD. “Both Certara and Paidion are passionate in their scientific commitment to developing safer medicines for children, as they are our most precious resource.”

	Paidion CEO Barry Mangum, PharmD, FCP, added, “Sick children represent the most vulnerable population in the world. As our understanding of pediatric patients has grown, we recognize that they manifest many diseases and side effects of the related medical treatments differently than adults. Combining Certara’s expertise in both pharmacokinetic/pharmacodynamic (PK/PD) and physiologically-based PK (PBPK) modeling with Paidion’s success rate in conducting pediatric clinical trials will be transformative.”

	Both FDA and the European Medicines Agency (EMA) have legislated that pharmaceutical companies must develop label guidelines for pediatric drug development. This requirement has resulted in an increased need for new scientific approaches, a clear aim of the Certara/Paidion partnership.

	One of the greatest challenges in pediatric clinical research is defining a safe and effective dose or dose range for this patient population that can span premature neonates to adolescents. There are significant physiological differences between children and adults that can affect the absorption, distribution, metabolism, and elimination (ADME) of medications. Certara has developed specific technologies and strategies to inform proper dose selection, including PK/PD simulations using sparse data analysis and its Simcyp® Pediatric PBPK simulator. The simulator captures changes in physiology and enzyme/transporter development that are particularly prominent in children from birth to two years of age. The Simcyp Simulator is used by most leading pharmaceutical companies and international regulatory agencies. In 2012, FDA voted unanimously in support of extending the use of PBPK modeling for pediatric drug development.

	In addition to physiological differences between pediatric populations, there are sizeable challenges in conducting pediatric clinical trials, which include study design, patient identification, recruitment and retention, and determining clinical benchmarks. The available pool of pediatric populations for many target indications is much smaller than adults, and ethical constraints signiï¬cantly limit the number of participants. Paidion’s pediatric focus, as well as its formation of sustainable neonatal and pediatric intensive care unit and pediatric clinical site networks will help resolve those challenges. 

	Current FDA and EMA guidelines recommend that dose selection for pediatric studies be based on all available prior information, starting with what has been learned in adult populations. This guidance translates into an ethical imperative to use biosimulation to inform pediatric drug development whenever possible, minimizing the impact on children that must enroll in clinical trials. At the same time, clinical trials are still a necessary part of drug development and they must be organized with a pediatric patient-centric focus. By combining expertise in biosimulation, pediatric clinical trial management, and regulatory strategy and writing, the Certara/Paidion partnership intends to greatly expand the number of new medications available to children.

Certara and Paidion Research Form Partnership Focused on Improving Pediatric Drug Development

	Cincinnati, OH ~ September 10, 2015- CTI Clinical Trial and Consulting Services (CTI), a multi-national, privately held, full-service contract research organization announces it recently collaborated with the Tuberous Sclerosis Alliance to analyze a Natural History Database of currently more than 1,700 people with tuberous sclerosis complex (TSC).

	 In 2006, the Tuberous Sclerosis Alliance, in partnership with a network of TSC Clinics, launched the TSC Natural History Database, the first-of-its-kind project to collect information about TSC, which affects various organs in the human body including the brain, heart, kidneys, lungs, liver, skin and eyes. TSC is also associated with developmental disorders such as autism. Written permission is obtained from an individual with TSC (or from the parent of a child or dependent adult with TSC) to enter clinical information from his or her medical record into the TSC Natural History Database, which is a web-based system. New clinical information is added to the database as it is documented in the individual’s medical record.  

	The analysis, performed by CTI and the Tuberous Sclerosis Alliance, was designed to compare various manifestations between genotypes and to determine if correlations exist between TSC symptoms and the TSC gene mutation. Data will be presented comparing various characteristics between TSC1 and TSC2 genotypes at the International TSC Research Conference: From Treatment to Prevention in Windsor, United Kingdom, taking place September 10-12, 2015. William Irish, PhD, Vice President, Biostatistics and Health Outcomes Research at CTI and one of the abstract’s authors, will make the presentation. 

	“We’re finding that groups like the Tuberous Sclerosis Alliance are becoming increasingly more important in drug development and research in rare diseases, as there is often a lack of information on rare disorders in published literature or traditional databases,” according to Joseph McCafferty, Vice President, North American Sales. “CTI is at the forefront in advancing these kind of collaborations and research efforts. We are very pleased to assist the Tuberous Sclerosis Alliance advance their mission to find a cure for tuberous sclerosis complex while improving the lives of those affected.” 

	“We are extremely proud to partner with CTI on presenting this important analysis on data collected in the TSC Natural History Database since 2006. For individuals and families who have participated in this important study, we are hopeful this type of information will help lead to scientific breakthroughs, ultimately improving the quality of life for those struggling with the daily challenges of TSC,” shared Kari Luther Rosbeck, President and CEO of the Tuberous Sclerosis Alliance.  

CTI Clinical Trial and Consulting Services Collaborated With Tuberous Sclerosis Alliance To Analyze Natural History Database

	NEW YORK, N.Y. – September 8, 2015 – 

 (NASDAQ: MDSO), the leading global provider of cloud-based solutions for clinical research in life sciences, today announced that its industry-leading technology platform has been adopted by 

, Ltd (“Walvax”) (SZSE: 300142), a biopharmaceutical company in China. Walvax is harnessing the 

 platform to improve data management activities and drive biomedical innovation in the development of a pneumococcal conjugate vaccine for infants.

	“Pneumococcal infections-including pneumonia, blood infections and meningitis-can be extremely difficult to treat, making prevention through vaccination a critical component of patient care,” said Yi Zhang, Vice President, Walvax. “We’re pleased to be using Medidata’s robust, globally-validated technology to bring greater speed and operational efficiencies to our pneumococcal conjugate vaccine trials, ultimately leading to a safe and effective way to ensure young children are protected from the devastating effects of pneumococcal diseases.”

	Founded in 2001, Walvax Biotechnology specializes in the research, development, production and distribution of bio-medicine products, including vaccines and blood products. To optimize the execution of its novel research on a vaccine for pneumococcal conjugate (PCV13)-the first multi-center clinical trials to be conducted on infants and toddlers in China-Walvax is utilizing Medidata’s cloud-based technology for electronic data capture and management (

). The Chinese biopharmaceutical company is also leveraging training available through Medidata’s professional services offering to speed study implementation and ensure trial timelines are met.

	"Medidata's cloud-based platform is designed to bring efficiencies to clinical trials of all sizes and therapeutics areas," said Takeru Yamamoto, Medidata’s managing director of the Asia-Pacific (APAC) region. "We’re proud to be collaborating with Walvax as the organization advances pneumococcal conjugate vaccine research in China, resulting in better preventative treatment for young people around the world."

Walvax Biotechnology Selects Medidata’s Cloud-Based Platform to Advance Pediatric Vaccine Program in China

Rho, a contract research organization (CRO) providing clinical research services in both the commercial and federal market, has been awarded a new cooperative agreement to provide statistical and clinical coordinating services to the Division of Allergy, Immunology and Transplantation (DAIT), National Institute of Allergy and Infectious Diseases (NIAID). The NC-based CRO will provide these services for DAIT’s large clinical research consortia in the areas of asthma and allergic diseases, autoimmune diseases, and transplantation.

	The largest federal contract in Rho’s 31-year history, the award is valued at approximately $16.5 million per year for seven years. Additionally, supplemental funds of approximately $6.8 million have been awarded for the first year. 

	“Rho is excited to be selected as DAIT’s Statistical and Clinical Coordinating Center to support the important work they are doing to help combat serious health concerns, such as asthma and allergies, autoimmune diseases, and transplantation,” said Russ Helms, Ph.D., Chief Executive Officer for Rho. “Rho’s expertise and resources will help assure top-notch operational support, statistical analysis, clinical data management and bioinformatics services.”

	The program uses a multiple principal investigator (PI) structure. Five Rho employees are serving as PIs on this project, including: Ronald W. Helms, Ph.D., Chairman and overall PI; Karen Kesler, Ph.D., Senior Statistical Scientist and Leadership Group PI; Samuel Arbes, Jr., D.D.S., M.P.H., Ph.D., Senior Research Scientist and Group Leader for the Asthma and Allergic Diseases Group; David Ikle, Ph.D., Senior Statistical Scientist and Group Leader for the Transplantation Group; and Lynette Keyes-Elstein, DrPH, Senior Statistical Scientist and Group Leader for the Autoimmune Diseases Group. Additionally, day-to-day management will be provided by Michelle Walter, M.S., Senior Project Director.

	The project combines services that were previously under six separate awards from DAIT – Rho held five of the previous awards. For additional details about Rho’s federal research expertise, visit 

Company Press Release

Articles

A Visual for the eClinical Landscape

Ways to Reduce Sample Size In Clinical Trials

Ways to Reduce Sample Size In Clinical Trials

Parexel Patient Centric DD PR

Clinerion Semicrol PR

ICON and IBM to Revolutionize Clinical Trial Feasibility, Patient Recruitment and Study Start-up Timelines

Certara and Paidion Research Form Partnership Focused on Improving Pediatric Drug Development

CTI Clinical Trial and Consulting Services Collaborated With Tuberous Sclerosis Alliance To Analyze Natural History Database

Walvax Biotechnology Selects Medidata’s Cloud-Based Platform to Advance Pediatric Vaccine Program in China

Rho Awarded New Federal Cooperative Agreement from National Institute of Allergy and Infectious Diseases