Category : HCC Press / News

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Sr. Clinical Research Associate Patti Lawrence Proctors Insertion of Sentry IVC Filter

Screen Shot 2016-02-10 at 12.49.44 PMWe pride ourselves on having clinical research associates (CRA) like Patti Lawrence, who go above and beyond during clinical trials. When Hart Clinical Consultants (HCC) was contracted by NOVATE Medical Ltd. to proctor physicians during the Sentry IVC clinical trial, CRA Patti Lawrence was called in to lead. Patti’s past experience in cath labs and knowledge of surgical etiquette made her the perfect CRA for this trial. Throughout the case, she guided physicians through procedures and, with little notice, made herself available to assist the sponsor at various U.S. locations as needed.

According to NOVATE, the bio-convertible Sentry IVC filter is designed to provide protection from PE during the period that a patient is at risk, and then bioconvert to a non-filtering configuration after a minimum of 60 days. This feature removes the requirement for an additional interventional procedure to retrieve the device. In addition, Sentry has a cylindrical frame that is designed to reduce the reported complications of existing IVC filter technologies, including tilt, migration, fracture, and vessel perforation. The procedure requires insertion of the device into a patient’s inferior vena cava, a large vein that carries deoxygenated blood to the heart and is designed to filter for blood clots so they don’t migrate to the lungs.

This is currently the only known medical device that actually bioconverts inside the body, meaning it can change once inside to react to its environment. It is a game changer.

Testing new devices and performing investigational procedures on patients can be stressful. In many instances, we must make ourselves available at a moment’s notice to catch a plane and head to a site. This is what makes HCC proctors unique, our ability to accommodate the sponsor when timing is critical to the success of their clinical trial.

We are always thrilled to get feedback from our clients and were pleased when NOVATE had only praise for their experience with Patti. “Patti’s knowledge and clinical experience has served us well. Not only is she confident, but she portrays that confidence and knowledge to those she comes in contact with. You have a gold mine.” What a ringing endorsement!

Patti Lawrence is one of the reasons we are unique among other CROs. Like Patti, each member of the HCC team has practical, hands-on, clinical expertise and proficiency in clinical trial operations. This is not the norm. This unique combination allows study sponsors to focus our resources where they are needed most at various times throughout the trial – whether that be in device training, case proctoring, site management or study monitoring. This reduces the number of committed staff for completing trial activities and often ensures the same person will be the sponsor’s point of contact throughout each trial.

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Hart Healthy Challenge: Get Active. Give Back.

#HeartMonth #HartHealthyChallenge

February is Heart Month, and in support of cardiac-health recognition, Hart Clinical Consultants (HCC) is getting active and giving back. By now, the New Year resolution hype is dying down and we are settling into 2016. Our goal is to remind everyone of one important resolution: be kind to yourself. Yes, that’s right! Let 2016 be the year where you step outside the chaos of life and focus on taking care of YOU!

To promote healthy living, we kicked off our Hart Healthy Challenge yesterday, February 1. HCC staff members are using Jawbone UP24 devices to track their steps throughout the month in a friendly competition. We are all making strides to walk, run, jog, hike, swim and bike more to show the effect an active lifestyle has on a healthy heart. Steps will be tracked on a daily basis and the top stepper at the end of each week will be recognized with a reward for their hard work.

For the grand finale of our Hart Healthy Challenge, the staff member who accumulates the most steps for the month of February will be awarded a $2,000 donation to give to their cardiac-related charity of choice. UPDATE:The second place stepper will be awarded $500 to donate to their cardiac-related charity of choice.

As the month progresses, watch our Twitter feed for updates on the HCC team’s progress and weekly steps! Get involved by sharing your own fitness progress using #HartHealthyChallenge. Even better, consider starting your own “Healthy Heart Month” challenge in your office. And remember, get moving for a healthier heart and a happier body!

Updated: Feb. 11, 2015

Hart Clinical Consultants Experiences Rapid Growth, Doubles Staff

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Stan Reaves Also Named Chief Operating Officer

ATLANTA (January 13, 2016) – Hart Clinical Consultants (HCC), a specialized and adaptable Clinical Research Organization (CRO) that conducts and manages all aspects of novel medical device and pharma clinical trials, has announced it has more than doubled it’s staff over the past six months.

The expansion has brought with it changes to HCC’s executive team. HCC’s former Director of Business Development Stan Reaves, has been promoted to chief operating officer. As COO, Reaves will lead HCC’s national consortium of highly-trained clinical research professionals in providing study sponsors with comprehensive regulatory and clinical support services, including case proctoring, monitoring and audit functions. He is also responsible for HCC’s project management and training programs.

Stepping up to fill Reaves’s shoes in the business development role is Patric Mercer. Mercer’s primary focus as manager of business development is growth and oversight of sales and marketing operations for HCC and assisting with clinical trial operations. Prior to joining HCC, Mercer was a practice administrator and clinical research manager for SleepMed, Inc., where he was responsible for day-to-day operations of SleepMed’s clinical facilities and all aspects of its clinical trial operations.

“We are extremely grateful to have been able to acquire such industry-leading talent over the past several months,” said HCC CEO Jim Hart. “It makes our national network of clinical trial professionals even stronger.”

Within the past six months, HCC also added 11 senior clinical research associates (CRA’s) to it’s ranks, to include: Kari Anderson, Jill Barnes, Janice Boyd, Beth Davis, Cheryl Fink, Helen Gleason, JoAnn Key, Larry Lobacz, Bryan Petrisko, Susan Wilson and Carol Anne Yarbrough. HCC’s senior CRA’s are the company’s back bone and are responsible for a host of integral duties, including procedure proctoring, site management and monitoring as well as working directly with sponsors/clients – all to ensure compliance with clinical trial protocols and the scientific integrity of all data collected.

To learn more about HCC’s national team of medical professionals and innovative services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive clinical research organization (CRO), providing staff augmentation and leadership throughout all phases of medical device and pharma/IND clinical trials. HCC has an industry leading staff of senior clinical research consultants and specialists across the country that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Juventus, CardioDx and Integrium. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

HCC Welcomes Anderson as Sr. Clinical Research Consultant/Sr. Research Specialist

ATLANTA – Feb. 2, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that Kari S. Anderson, Ed.D, MSN, RN, CCRAhas joined HCC as a senior clinical research consultant and senior clinical research specialist. In this role, Dr. Anderson will manage all aspects of clinical trial operations and provide training support for innovative medical devices and procedures.

An accomplished educator, medical affairs specialist and experienced clinical research associate (CRA) with more than 20 years of clinical experience, Dr. Anderson has demonstrated accomplishments in clinical monitoring, project management, creative instructional strategies, and global clinical research and development. She has been recognized for exceptional collaboration and leadership skills, cross-functional team development, and innovative problem solving aptitude.

With extensive device and pharmaceutical experience in multiple therapeutic areas, Dr. Anderson was most recently a regional CRA for Anderson Clinical Consultants inWestminster, MD. In this role, she was responsible for negotiating contractual agreements to maximize value, cost effectiveness and strategic alignment; monitoring all phases of medical device and pharmaceutical clinical trials; and monitoring assigned clinical sites to ensure all study activities were conducted efficiently, meet enrollment goals and were in compliance with all applicable regulations. She also helped develop monitoring and communication best-practice tools.

Dr. Anderson also held positions with Abbott Medical Optics in Santa Ana, CA as east coast regional manager and principal CRA, and at Abbott Laboratories in Abbott Park, IL as senior clinical manager, outsourcing.

Dr. Anderson received her Bachelor of Science in Nursing from the University of Minnesota and her Master’s of Science in Critical Care Nursing from Duke University. She earned her Doctorate in Adult Education from North Carolina State University.

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 About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com.

Hart Clinical Consultants Welcomes Barry as Senior Clinical Specialist/Research Associate

ATLANTA – Jan. 21, 2015 – Hart Clinical Consultants (HCC), a novel medical device training, proctoring and monitoring company announced that William Barry RN, CCRA has joined the organization as a senior clinical specialist/research associate. Mr. Barry will manage all aspects of clinical trial operations and proctors procedures for innovative medical devices and operate out of the organization’s headquarters in Atlanta.

Prior to joining HCC, Mr. Barry was with Abbot Vascular for nearly 14 years, serving in various roles including clinical operations manager, field clinical research associate, territory manager and clinical coordinator and manager. In his most recent role, he was responsible for hiring, training and managing a group of 5-8 Field CRA’s in the U.S. Mr. Barry also was responsible for project management, protocol writing/review and CRF design. During his time with Abbot Vascular, Mr. Barry oversaw numerous areas including being in charge of sales and training, site assessments, site initiations, monitoring, case proctoring, site support for AV clinical trials and more.

Prior to joining Abbot Vascular, Mr. Barry worked as a staff nurse at Atlanta Medical Center/Georgia Baptist. He holds an associate’s degree in nursing from DeKalb University and a Bachelor of Science degree in biology from Oglethorpe University. In addition, Mr. Barry received EMT and LPN training from the United States Army.

To learn more about HCC’s full team of medical professionals and services, visit www.hartclinicalconsultants.com

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About Hart Clinical Consultants: Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials. HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

Hart Clinical Consultants Names New Management Staff

Director of Clinical Operations & Business Development Among New Positions

   Boris Jelercic Headshot HCC   bio_stan   HCC Tony Sestrich headshot

MELBOURNE BEACH, FL (October 17, 2014) – Hart Clinical Consultants (HCC), a global medical device clinical trial management company, is pleased to announce the promotion of Mr. Stan Reaves to HCC Director of Business Development and the addition of Mr. Boris Jelercic as Director of Clinical Operations.

As HCC’s Director of Clinical Operations, Jelercic (based in St. Louis, MO) will be responsible for managing the tactical operation of ongoing clinical trials, ensuring quality and timeline metrics are achieved on behalf of clients. Additionally, Jelercic will have responsibility for personnel functions and recruitment of new HCC staff. Prior to joining HCC, Jelercic served as a clinical project manager for Abbott Vascular and J. Tyson and Associates.

As HCC’s Director of Business Development, Stan Reaves (based in Atlanta) will be responsible for generating new client business and implementing HCC’s quality service program. Stan is being promoted from Sr. Field CRA and Case Proctor at HCC, and has also previously served as a Sr. Field CRA for Abbott Vascular.

In addition, Hart Clinical Consultants has hired a new senior clinical research specialist – Mr. Tony Sestrich, RN/CCRA (Palm Springs, CA). Sestrich is a 35-year medical trial veteran previously functioning as Sr. Clinical Research Associate with Abbott Vascular and with additional prior experience at Guidant Corporation, California Pacific Medical Center and the Arizona Heart Institute.

“We are extremely fortunate to attract the level of industry talent we have at HCC,” said HCC President Jim Hart. “With backgrounds working for such successful brands as Abbott Vascular and Guidant, we bring a breadth of experience to our medical device clients that is unprecedented in the industry.”

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About Hart Clinical Consultants:Hart Clinical Consultants is a comprehensive trial management organization (TMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials.HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Velomedix. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

HCC Partners with Orlando-Based Realtime Clinical Consulting – Agreement expands HCC’s Regional Coverage Across Southeast and Mid-Atlantic Regions

ORLANDO, FL. (September 22, 2014) – Hart Clinical Consultants (HCC), a global medical device clinical trial management company, is pleased to announce a new staffing partnership with Orlando-based Realtime Clinical Consulting, a medical staffing agency specializing in providing on-site solutions for medical device clinical trials.

The new, collaborative business arrangement will provide business development benefits to both companies and will add Orlando and Raleigh, North Carolina-based staffing expertise to HCC’s growing global staff.

New additions to the HCC work team via Realtime Consulting include Kathy Potter, RN/CCRA and Graham Lovell, RN/CCRA, both based in Orlando, as well as Jim Kneller, RN/CCRA of Raleigh.

“These three, seasoned professionals offer diverse therapeutic backgrounds to HCC clients and will enhance our current site selection, trial monitoring and training offerings in the southeastern and mid-Atlantic regions,” said HCC President Jim Hart. “We look forward to a long and successful working relationship with Realtime.”

For more information about Realtime Clinical Consulting, visit http://realtimecra.com.

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About Hart Clinical Consultants:Hart Clinical Consultants is a comprehensive study management organization (SMO) providing staff augmentation and leadership throughout all phases of medical device clinical trials.HCC has an industry leading staff of Senior Clinical Research Consultants and Specialists that integrate directly into host environments, providing expert proctoring, training, monitoring and oversight for medical device trials. Hart Clinical Consultants has a proven history of securing thorough and timely results for such high-profile brands as Stryker, ResMed, Avinger and Juventas Therapeutics. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com

HCC President Honored by University of Central Florida

Clinical Trial Consultancy CEO Bestowed With Professional Achievement Award

ORLANDO (March 17, 2014) – Jim Hart, a University of Central Florida (UCF) alumni and President of Hart Clinical Consultants, a national clinical trial consultancy formed in Orlando, was recently selected by the UCF College of Nursing as a recipient of its Professional Achievement Award.

Jim founded Hart Clinical Consultants in 2011 to provide ensure clinical and regulatory activities are conducted expertly in domestic and international clinical trials.

Throughout his career, Hart has served in a range of medical roles around the country – from registered nurse to clinical researcher – with high-­‐profile organizations, including Florida Hospital, Abbott Vascular, Guidant Corporation, and Advanced Cardiovascular Systems, among others.

As the Owner and Chief Executive Officer of Hart Clinical Consultants (HCC), Jim Hart partners with medical device, pharmalogical and biomedical pioneers to conduct clinical trial operations that bring technology and innovation to market. His areas of expertise include cardiovascular, endovascular, neurovascular, and respiratory medicine, as well as diabetes care.

Hart formed HCC due to a need in the marketplace to supply highly skilled technical advisors to provide a liaison role between medical and hospital support staff at clinical trial sites. HCC now boasts a staff of 12 and is an industry leader in integrating with and training medical personnel on the proper prep, set-­‐up and use of such devices in a variety of clinical settings, ensuring established indications for use and protocols are expertly followed.

“I feel absolutely blessed to have had the educational experiences I had at the UCF College of Nursing,” said Hart. “The instructors challenged me both academically and clinically. When I graduated, I felt well prepared to tackle my medical career.”

Jim maintains active licensure as a registered nurse in Florida and Vermont and has a Bachelor of Science degree in Nursing from UCF. Jim is also credentialed as a CCRA, Certified Clinical Research Associate, through the Association of Clinical Research Professionals.

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About Hart Clinical Consultants (HCC): Hart Clinical Consultants is a staff augmentation organization, providing integrated management of professional clinical trials for medical device manufacturers within healthcare environments. For more information, follow @HartClinical on Twitter or visit www.hartclinicalconsultants.com