Drug Industry News Day_2_Tuesday_June_16_2015 : Page 6

6 2nd Edition • Tuesday, June 16, 2015 A: Central labs play an increasingly im-portant role in RBM, as they have a mul-titude of applications that are largely underutilized in today’s environment to help minimize errors, lower costs, im-prove analytical insight and expedite re-sults. For example, through Smarter Testing, sponsors are able to gain access to crucial central lab data that can be leveraged to improve patient screening by assuring trial candidates fall within the protocol’s parameters. Q: Does Smarter Testing provide any additional benefits to the patient? A: By focusing only on what is necessary to prove the safety and efficacy of a drug, Smarter Testing helps sponsors signifi-cantly improve patient safety and support as they move their products forward in the development lifecycle. Keeping in mind that organ toxicity is the most com-mon cause of safety-related drug with-drawal, sponsors using the Smarter Testing approach can proactively consult with their central labs to assess a drug’s adverse effect on vital organs. Central labs can also choose an appropri-ate set of screening diagnostics to not only enroll the most appropriate patients as quickly as possible, but also enable early pattern recognition in test results that can be used to effectively measure continued on page 15 Leading the Way in Smarter Testing Mark Engelhart is Chief Commercial Officer at ACM Global Central Lab-oratory, where he manages the global business devel-opment, marketing, com-mercial analysis, and bids and contracts functions. Q: Throughout recent years, clinical trial proto-cols have grown im-mensely in terms of costs and complexity. What considerations should biopharmaceu-tical companies and clinical research organizations have when planning for clinical diagnostic testing? A: It’s become increasingly important for drug developers to take proactive meas-ures to optimally position their clinical trials for success and gain a competitive advantage in introducing their new drugs to the market. At ACM, we have devel-oped a unique approach in which spon-sors engage with our central lab scientific experts early in the protocol development process, first by characterizing the de-sired study outcomes, and then identify-ing the endpoints and selecting the lab tests that will ultimately support those outcomes. We call this approach Smarter Testing. Q: How does Smarter Testing help drug devel-opers overcome the challenges frequently encountered during the clinical trial process? A: By conducting an ex-pert laboratory review early in the protocol devel-opment process, the central lab is able to ensure that all critical milestones can be achieved within the indicated time and cost parameters, as well as ensure optimal use of resources, without increasing the risks associated with the trial. With an immense array of testing options available, today’s test selection process is more complex than ever — especially when novel or esoteric laboratory analy-ses are considered. When the endpoints that will support desired outcomes have been clearly defined, appropriate testing options can be more easily identified. Q: As more trials move toward a risk-based monitoring (RBM) approach, how can Smarter Testing help mitigate risk? An independent publication not affiliated with any other organization Gary Cox Publisher Steve Cox John McQuaig Andrew Oseman Senior Associate Publishers Michael Harris National Sales Director Lyle Sapp National Sales Manager Don Bomeisl Sharon Collins Rebecca Creger Lynn Hardy Richard Mandziak Bill Morris Ozzie Ozolins Jeff Rosano Associate Publishers Valerie Wilson Art Director Elena Cruz Ginette Gonzalez Editors Krystal Hutchinson Traffic Manager Monique Carter Julie Evans Tiffany Webster Administration Drug Industry News is published by Source Group LLC ©2015. All rights reserved. Business License #45-4600703 6979 East Broadway Blvd., Suite 109 Tucson, AZ 85710 phone: (520) 722-2000 • fax: (520) 722-2014 www.sourceg.net Clinical Trial Data Sharing: A Framework for Success Article Courtesy of KAI Research, Inc. The many stakeholders involved in clin-ical research — patients, volunteers, in-vestigators, sponsors and others — agree that data sharing is essential, but it is hardly routine in the current clinical trial lifecycle. In effort to address challenges in sharing clinical trial data, the Institute of Medicine (IOM) assembled a commit-tee to review strategies for responsible data sharing and to establish a framework and guiding principles for data sharing. KAI is committed to implementing data-sharing activities as early in the study de-sign as possible. We use a standardized case report form (CRF) library, data dic-tionaries and standardized data vocabu-lary (i.e., Clinical Data Interchange Standards Consortium terminology) in our clinical databases to be utilized across studies. These processes build ef-ficiencies into both the study design and the data sharing processes. We recognize that data sharing comes with costs. Establishing and main-taining databases and technology plat-forms for storing large datasets has a cost, as does maintaining the technical expert-ise required to prepare materials and data for sharing. One of the challenges that IOM iden-tified is the accurate measurement of these various data sharing areas — technology, work-force, infrastructure and sustainability — in order to measure the return on investment resulting from data sharing. We at KAI believe that the effort to identify and overcome these challenges is worth the costs; from innovative new trials to, ultimately, cures, there is tremendous potential benefit to public health. KAI is a full-service contract re-search organization (CRO) and health re-search company. Since 1986, we have helped pharmaceutical, ac-ademic and federal clients bring innovative drug treatments and other inter-ventions to market by sup-porting early clinical Phase I studies through Phase III trials and post-marketing efforts. We streamline clin-ical research activities through the implementation of robust, standard processes and integrated eClin-ical solutions. For more information on KAI services, call 301-770-2730, visit www.kai-research.com, or stop by Booth #2740 at DIA 2015. If you have any questions, please contact Patti Shugarts at 301-770-2730 or email kaimarketing@kai-research.com. time by more than 50 percent and an in-crease in subject retention rate of more than 95 percent are among the results that have spurred GlobalCare’s rapid growth. “Oncology, rare diseases, neurologic dis-orders and infectious diseases are among the therapeutic areas most demanding of these services,” said Adinamis. “In addi-tion to study drug administration, blood draws and clinical assessments at home,” Adinamis continued, “we also provide travel companion services to assist pa-tients to the site and within a site as well as a variety of onsite support services for the investigative staff.” GlobalCare is a global niche service continued on page 15 Patient-Centric Study Visits Conducted at Home Improves Recruitment/ Retention and Speeds Trials GlobalCare Clinical Trials, Ltd continues expansion of patient-centric services to more than 40 countries across five conti-nents. GlobalCare provides selected clini-cal study visits at patients’ homes, workplace or alternate settings to support phase I-IV trials across a variety of thera-peutic areas and orphan drug studies. CEO, Gail Adinamis, states, “Our patient-centric service model provides faster pa-tient recruitment, better protocol compli-ance and higher retention rates, while decreasing development time. Our model was built on the simple premise that if you make study participation convenient and comfortable, more patients will be willing and able to participate.” Adinamis founded and pioneered the service model which she introduced more than 20 years ago. GlobalCare centrally manages a net-work of multilingual, GCP/ICH certified country coordinators who have an in-depth knowledge of local medical prac-tices, country regulations and cultural attitudes. The network is augmented by an extensive pool of more than 25,000 qualified local traveling physicians and study nurses across North America, Latin America, Europe and Asia-Pacific. Reduction in subject recruitment

Leading the Way in Smarter Testing

Mark Engelhart is Chief Commercial Officer at ACM Global Central Laboratory, where he manages the global business development, marketing, commercial analysis, and bids and contracts functions.

Q: Throughout recent years, clinical trial protocols have grown immensely in terms of costs and complexity. What considerations should biopharmaceutical companies and clinical research organizations have when planning for clinical diagnostic testing?
A: It’s become increasingly important for drug developers to take proactive measures to optimally position their clinical trials for success and gain a competitive advantage in introducing their new drugs to the market. At ACM, we have developed a unique approach in which sponsors engage with our central lab scientific experts early in the protocol development process, first by characterizing the desired study outcomes, and then identifying the endpoints and selecting the lab tests that will ultimately support those outcomes. We call this approach Smarter Testing.

Q: How does Smarter Testing help drug developers overcome the challenges frequently encountered during the clinical trial process?
A: By conducting an expert laboratory review early in the protocol development process, the central lab is able to ensure that all critical milestones can be achieved within the indicated time and cost parameters, as well as ensure optimal use of resources, without increasing the risks associated with the trial.

With an immense array of testing options available, today’s test selection process is more complex than ever — especially when novel or esoteric laboratory analyses are considered. When the endpoints that will support desired outcomes have been clearly defined, appropriate testing options can be more easily identified.

Q: As more trials move toward a riskbased monitoring (RBM) approach, how can Smarter Testing help mitigate risk?
A: Central labs play an increasingly important role in RBM, as they have a multitude of applications that are largely underutilized in today’s environment to help minimize errors, lower costs, improve analytical insight and expedite results. For example, through Smarter Testing, sponsors are able to gain access to crucial central lab data that can be leveraged to improve patient screening by assuring trial candidates fall within the protocol’s parameters.

Q: Does Smarter Testing provide any additional benefits to the patient?
A: By focusing only on what is necessary to prove the safety and efficacy of a drug, Smarter Testing helps sponsors significantly improve patient safety and support as they move their products forward in the development lifecycle. Keeping in mind that organ toxicity is the most common cause of safety-related drug withdrawal, sponsors using the Smarter Testing approach can proactively consult with their central labs to assess a drug’s adverse effect on vital organs.

Central labs can also choose an appropriate set of screening diagnostics to not only enroll the most appropriate patients as quickly as possible, but also enable early pattern recognition in test results that can be used to effectively measure patient safety.

To download a copy of ACM Global Central Laboratory’s Smarter Testing eBook, “Using Smarter Testing Strategies to Optimize Clinical Protocol Development,” visit: www.acmgloballab.com/smarter. Visit Booth #2221 for more information.

Read the full article at http://pubs.royle.com/article/Leading+the+Way+in+Smarter+Testing/2022922/260843/article.html.

Clinical Trial Data Sharing: A Framework for Success

Article Courtesy of KAI Research, Inc.

The many stakeholders involved in clinical research — patients, volunteers, investigators, sponsors and others — agree that data sharing is essential, but it is hardly routine in the current clinical trial lifecycle. In effort to address challenges in sharing clinical trial data, the Institute of Medicine (IOM) assembled a committee to review strategies for responsible data sharing and to establish a framework and guiding principles for data sharing. KAI is committed to implementing datasharing activities as early in the study design as possible. We use a standardized case report form (CRF) library, data dictionaries and standardized data vocabulary (i.e., Clinical Data Interchange Standards Consortium terminology) in our clinical databases to be utilized across studies. These processes build efficiencies into both the study design and the data sharing processes.

We recognize that data sharing comes with costs. Establishing and maintaining databases and technology platforms for storing large datasets has a cost, as does maintaining the technical expertise required to prepare materials and data for sharing. One of the challenges that IOM identified is the accurate measurement of these various data sharing areas — technology, workforce, infrastructure and sustainability — in order to measure the return on investment resulting from data sharing.

We at KAI believe that the effort to identify and overcome these challenges is worth the costs; from innovative new trials to, ultimately, cures, there is tremendous potential benefit to public health.

KAI is a full-service contract research organization (CRO) and health research company. Since 1986, we have helped pharmaceutical, academic and federal clients bring innovative drug treatments and other interventions to market by supporting early clinical Phase I studies through Phase III trials and post-marketing efforts. We streamline clinical research activities through the implementation of robust, standard processes and integrated eClinical solutions.

For more information on KAI services, call 301-770-2730, visit www.kai-research.com, or stop by Booth #2740 at DIA 2015. If you have any questions, please contact Patti Shugarts at 301-770-2730 or email kaimarketing@kai-research.com.

Read the full article at http://pubs.royle.com/article/Clinical+Trial+Data+Sharing%3A+A+Framework+for+Success/2022923/260843/article.html.

Patient-Centric Study Visits Conducted at Home Improves Recruitment/ Retention and Speeds Trials

GlobalCare Clinical Trials, Ltd continues expansion of patient-centric services to more than 40 countries across five continents. GlobalCare provides selected clinical study visits at patients’ homes, workplace or alternate settings to support phase I-IV trials across a variety of therapeutic areas and orphan drug studies. CEO, Gail Adinamis, states, “Our patientcentric service model provides faster patient recruitment, better protocol compliance and higher retention rates, while decreasing development time. Our model was built on the simple premise that if you make study participation convenient and comfortable, more patients will be willing and able to participate.” Adinamis founded and pioneered the service model which she introduced more than 20 years ago.

GlobalCare centrally manages a network of multilingual, GCP/ICH certified country coordinators who have an indepth knowledge of local medical practices, country regulations and cultural attitudes. The network is augmented by an extensive pool of more than 25,000 qualified local traveling physicians and study nurses across North America, Latin America, Europe and Asia-Pacific.

Reduction in subject recruitment time by more than 50 percent and an increase in subject retention rate of more than 95 percent are among the results that have spurred GlobalCare’s rapid growth. “Oncology, rare diseases, neurologic disorders and infectious diseases are among the therapeutic areas most demanding of these services,” said Adinamis. “In addition to study drug administration, blood draws and clinical assessments at home,” Adinamis continued, “we also provide travel companion services to assist patients to the site and within a site as well as a variety of onsite support services for the investigative staff.”

GlobalCare is a global niche service provider to government agencies and the world’s biotechnology, pharmaceutical and medical device companies engaged in all phases of product development. GlobalCare offers an innovative patient-centric service model that provides selected clinical study visits in the home or alternate setting resulting in faster patient recruitment, better compliance and higher retention rates, helping to expedite time-to-market for life-enhancing products. GlobalCare’s model enables patients to participate in clinical trials regardless of study duration; frequency of visits; disease state; distance to site; and/or family, work or community commitments by conducting study visits in a location convenient to them.

Services include Global Project Management, study drug administration, blood and other biologic sample collection, clinical assessments, patient training and education, device management, source documentation and data collection. In addition, the company offers out-patient pharmacy services including storage and distribution across the country, compounding and dispensing, cold chain logistics and sourcing of commercial products and devices. GlobalCare also offers a variety of site support services to assist sites in being more productive.

For more information call 847-282- 3280, visit www.globalcarect.com, or visit them at Booth #2729.

Read the full article at http://pubs.royle.com/article/Patient-Centric+Study+Visits+Conducted+at+Home+Improves+Recruitment+Retention+and+Speeds+Trials/2022924/260843/article.html.

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