Breakthrough Medical Imaging

Scientific oversight by the brightest minds in the business

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We know your business is complicated, just like the regulatory process.

After supporting hundreds of studies across many therapeutic areas, our medical experts collectively create a wellspring of institutional knowledge to simplify your journey.

This experience and scientific expertise enables us to create clarity around how to:

  • Craft the charter
  • Define imaging parameters
  • Qualify sites
  • Shape submissions
  • Manage image standardization
  • Review and analyze images
  • Work with the worldwide regulatory agencies

Imaging-intense trials are complicated, and have incredibly high stakes. In a market that moves this fast, you want to get these trials right…from the beginning.

Want to know that you're working with medical experts who know your field?

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Access our resource center to help expand your knowledge

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What's Your Therapeutic Area?

Our scientific experts have led some of the most transformative therapies in medicine. Browse through their insights.

Oncology is currently the largest component of our imaging business, with over 50% of our engagements in the full array of oncology indications. PAREXEL’s oncology team supports independent reviews for both road tested and novel criteria, such as the new lymphoma criteria (Lugano Classification), irRC and the new irRECIST for immunotherapy, brain metastases in solid tumor, modifications to RECIST 1.1, tumor Volumetric assessments and FDG-PET qualitative and semi quantitative assessments. PAREXEL manages a wide range of expedited reading workflows, including eligibility confirmation based on inclusion criteria and confirmation of PD.  Additionally, the team has pioneered novel trial designs for breakthrough therapies, including audit methodologies as outlined by ODAC in July 2012 and has close integration with industry forums, such as QIBA and PINTAD.

At PAREXEL, our primary goal for Musculoskeletal (MSK) trials is to provide accurate and precise assessments by expert readers. To achieve this goal we ensure standardization in image acquisition by providing imaging templates, positioning devices, and monitoring instrument quality control, as well as, consistent scanner calibration across sites within a study.  Standardization of image acquisition allows optimal image quality at baseline and consistent imaging with baseline at follow-up; this results in increased sensitivity and power to demonstrate treatment effects; PAREXEL staff will compare the results of all follow up scans to baseline to ensure consistent positioning across timepoints.  Additionally, due to the technical nature of MSK assessments, PAREXEL supports the selection and management of readers and has the bandwidth to ensure a small pool of readers for each trial to limit inter-reader variability while also meeting your timelines.

We provide a wide range of services for CNS imaging clinical trials.  Our network of scientific advisors and in-house expertise allows for full spectrum services offerings to help take your product from discovery to market.  We have experience with any standard modality used at your investigators' sites for routine imaging of CNS patients including advanced functional MRI, conventional MRI, CT and angiography. With a team of experienced in-house medical imaging experts, including imaging physicists, a dedicated Exploratory Imaging group, and world class partnerships we are equipped and well-positioned to help you gain the information needed from new and less established imaging methods.

Inclusion of standardized cardiovascular (CV) imaging endpoints in clinical trials is becoming increasingly valuable, often resulting in an accelerated understanding of a drug's effect on CV efficacy and safety. As a leading imaging core lab for clinical trials with CV efficacy and safety endpoints we offer broad expertise and experience in handling the cardiovascular imaging needs of small and large scale studies, across multiple therapeutic areas and with all major CV imaging modalities.  We are able to provide quantitative assessments, such as cardiac volumes, dimensions and calculation of ejection fraction, as well as qualitative assessments, for example, regional and global ventricular wall motion abnormalities, valvular anatomy and function. These assessments are typically made using either proprietary image viewing software and systems, or state-of-the-art third party software.  PAREXEL is proud to have supported 8 regulatory approvals that included the assessment of CV safety.

With PAREXEL® Informatics you are fully supported by our medical expertise including in-house trained and practicing sonographers with nearly 45 years of actual clinical experience. PAREXEL has extensive experience in the industry running Women’s Health studies that have required the acquisition, collection, standardization, and/or independent review of imaging for clinical endpoints. This includes; transvaginal ultrasound (TVU), transabdominal ultrasound (TAU), saline infused sonohysterograms (SIS), hysteroscopy videos, and MRI. Centralizing the collection and analysis of ultrasound is imperative as the modality is generally subjective, based on the local sonographer’s training and preferences.  Ensuring appropriate acquisition requires a unique set of guidelines, experience, and training. PAREXEL Informatics has eight on-staff radiologists and four experienced sonographers, one of whom is registered and still practicing clinically. 

In addition to standard endoscopies (colonoscopies, flexible sigmoidoscopies, and upper GI endoscopies) the use of cross-sectional imaging techniques for suspected small bowel disorders has increased over the past several years. Cross-sectional imaging, such as CT and MRI, allow visualization of the entire bowel, without overlapping bowel loops, and detection of extraluminal pathologic conditions. Improvements in MRI hardware and software have enabled MRI to assume a major role in the evaluation of the small and large bowel. MRI has several advantages, such as a lack of ionizing radiation (good for repeat imaging) and excellent soft tissue contrast. PAREXEL has more than a dozen fulltime experts (technologists, gastroenterologists, PhDs, MDs, and radiologists, as well as, global resources to process and independently review GI videos around the clock.  PAREXEL will train investigator sites on the qualitative scoring criteria and how to best acquire the video to reduce site / central analysis discordance.  Additionally, PAREXEL’s methods improve the site experience by ensuring high quality data without burdening the sites with additional recording device hardware. For colonoscopy trials where central reviewers need to be mobile, PAREXEL® Informatics has developed a unique workflow to allow reviewers to conduct their reads on iPads, in any location with internet access. 

The PAREXEL® Informatics medical imaging team supports pharmaceutical clients in the investigation of new therapies for various ophthalmic diseases by leveraging its proven global clinical trial support and partnerships with key academic leaders. PAREXEL has experience executing large phase II/III trials whereby ophthalmic imaging assessments are being used to support both safety and efficacy outcomes using the following imaging modalities:

  • Spectral Domain Optical coherence tomography (SD-OCT)
  • Color fundus photography (CFP)
  • Fundus autofluorescence (FAF); Confocal Scanning Laser Ophthalmoscopy (cSLO)
  • Fluorescein angiography (FA); Indocyanine Green Angiography (ICG)
  • Ultra-wide field angiography, Photography
  • Slit lamp/Iris Photography
  • Specular microscopy for endothelial cell counts

PAREXEL® Informatics Medical Imaging is one of the world’s most experienced providers for centralized independent review services and excels in the management of respiratory trials.  PAREXEL is proud to have supported the imaging component of respiratory drugs that received breakthrough approval. Five years ago, the medical imaging group expanded services beyond traditional imaging to include management and central review of surgical lung biopsies. PAREXEL is partnering with some of the brightest minds in the respiratory space and device providers and are proud to expand services to provide full one-stop-shop for all central review services for respiratory trials including; medical imaging, pathology, and spirometry. 

PAREXEL’s Medical Imaging global offering provides a complete solution for image management, site support, central repository, and independent review for all radiological and photographic needs. Photographic components of a clinical trial are fully integrated with other centrally reviewed modalities including, CT, MRI, and many others increasing quality, improving investigator site compliance, streamlining independent review, thus reducing turnaround times.  Selecting PAREXEL® Informatics as your core lab to manage photographic and radiographic imaging, eliminates the cost of hiring a separate third-party photography vendor. Our services include complete photography management solution which includes camera and photo management. PAREXEL Informatics is responsible for training sites on appropriate photo acquisition.  Additionally, we provide site support by purchasing photographic equipment on behalf of Sponsors. We assemble, set camera defaults, test and ship all required photographical equipment to the investigator sites, and maintain ongoing camera management and site support for the duration of the trial.  Our team will confirm consistency in parameters and photo quality across timepoints and ensure that image magnification and image size is acceptable. 

Volumetric assessments of organs or lesions are an increasing area of clinical trial investigation. PAREXEL’s medical imaging group, has been performing centralized volumetric assessments since 1998. Currently, PAREXEL is very active in the Quantitative Imaging Biomarker Alliance (QIBA). Specifically, Dr. Rudresh Jarecha DMRE, DNB, Associate Medical Director has been deeply involved in the CT Volumetry Technical Committee.  Furthermore, with his initiative and support, PAREXEL participated in a QIBA Volumetric CT 3A Challenge – PIVOTAL Study which evaluated algorithmic variability in the estimation of lung nodule volume from phantom CT scans.  PAREXEL has co-authored the associated paper which was reviewed by National Institute of Standards and Technology (NIST).  Additionally, PAREXEL participated in QIBA 3A Volumetry Study of CLINICAL data for NSCLC. Benefiting from the breadth and depth of internal experts, PAREXEL has developed technology and methods for the evaluation of a wide range of medically relevant volumes.

Experience and Passion:

Profiles of our Scientific Medical Experts

Additional Scientific Advisors

Sally Warner

Sally Warner

Senior Medical Director, Musculoskeletal Imaging


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Sally (Sarah) Warner, Ph.D., CCD

Development Area:
 Medical Imaging
Lead Therapeutic Area(s): Musculoskeletal
Geographic Responsibility: 
Global

Sally joined PAREXEL Informatics in 2006. She provides scientific expertise in study design, protocol standardization, and customization of analysis software tools for musculoskeletal clinical imaging trials. She is also responsible for quality and regulatory compliance of deliverables.

Work Experience

Sally has nearly 20 years of experience in imaging for musculoskeletal research trials. Sally’s previous experience includes certification by the International Society for Clinical Densitometry (ISCD) as a clinical densitometrist and a dual-energy X-ray absorptiometry (DXA) technologist, as well as Radiology Practicing Technologist License in the state of Utah; making her perfectly suited to assist investigator sites in proper scan acquisition. She has held positions as senior research assistant at the University of Connecticut Health Center, research fellow at the University of Utah and senior research fellow in the department of Orthopaedics and Sports Medicine at the University of Washington. Sally’s musculoskeletal research has included the use of many different

modalities for the assessment of bone metabolism including bone histomorphometry, 3-point bending, radiography, ultrasound (US), DXA, quantitative computed tomography (QCT), and high resolution computerized tomography (HrCT) imaging. During her tenure at PAREXEL, Sally has managed the medical and scientific aspects of imaging for more than 65 clinical trials in rheumatology (rheumatoid arthritis (RA), psoriatic arthritis (PsA), spondyloarthropathy (SpA), ankylosing spondylitis (AS) and osteoarthritis (OA)), orthopedics and body composition. These trials have included the use of radiography, CT, Dual-energy computed tomography (DECT), QCT, DXA, US and magnetic resonance (MR) imaging with a variety of qualitative and quantitative assessments.

Education

Sarah received her B.A. in biology and exercise science from Skidmore College, a master’s degree in exercise physiology from the University of Connecticut and her Ph.D. from the University of Utah.

Kenneth G. Faulkner

Corporate VP - Medical Imaging


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Kenneth G. Faulkner, Ph.D.

Development Area: Medical Imaging
Lead Therapeutic Area: Musculoskeletal
Geographic Responsibility: Global

Ken joined PAREXEL in 2008 and has global responsibility for the medical imaging business. He provides operational, medical and technological leadership in support of imaging biomarkers in early-to-late-phase programs across various indications and therapeutic areas. Ken also works with other PAREXEL business units to provide technology solutions for the biopharmaceutical research market.

Work Experience

Prior to joining the PAREXEL family, Ken was co-founder of Synarc, Chief scientist and global director of product development at GE Healthcare, and spent nine years at Oregon Osteoporosis Center where he built and directed the biomarker laboratory operation.

Education

At the University of California, San Francisco, he received both his master’s and doctorate degrees in biomedical engineering and served as an assistant professor of radiology. Ken has had numerous articles published on rheumatology and osteoporosis.

Peter Steiger

Peter Steiger

Vice President and Chief Scientific Officer, Medical Imaging


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Peter Steiger, Ph.D.

Development Area: Medical Imaging
Lead Therapeutic Area(s): Musculoskeletal
Geographic Responsibility:Global

Peter joined PAREXEL in 2014 and leads the medical and scientific team at PAREXEL Informatics Medical Imaging, which is comprised of a global team of over 30 MD, Ph.D., and scientists. He has a wealth of experience in the use of imaging in academic research, medical device development and clinical trials management. His responsibilities include both the oversight of the medical team as well as the expansion of PAREXEL’s Medical Imaging business into new areas.

Work Experience

Peter started his academic career at the University of California, San Francisco under the direction of Dr. Harry K. Genant, where he was involved in multiple publicly and privately funded research projects in skeletal radiology.

In 1990 Peter left academia to work at Hologic, Inc. As Chief Scientist, he was involved in the development of new product concepts and strategies, product development, planning and execution of clinical research for product validation, preparing regulatory submissions,

and supporting the field service, marketing, and manufacturing departments. During his tenure at Hologic, Peter also created a division which provided image quality assurance services to pharmaceutical companies in support of clinical trials.

Later, Peter joined Synarc, Inc., a privately-held, venture-backed company for the support of imaging in clinical trials. During his tenure as CEO, Synarc grew to become one of the world’s leading dedicated providers of centralized imaging services, an organization with 350 employees in 5 countries.

Peter returned to the medical device industry when he joined Optasia Medical LTD. as CEO in 2006, and where he helped close an initial round of financing to help launch the company. Optasia Medical makes and sells FDA cleared software that is used in a point-of-care setting for the documentation of vertebral fractures.

Throughout his career, Peter has been actively engaged in research, has authored numerous papers and is regularly involved in research presented at scientific meetings.

Education

Peter studied electrical engineering and computer science at the ETH in Zurich, Switzerland and received his Ph.D. degree in Biomedical Engineering for work on the quantification of subchondral bone loss in rheumatoid arthritis. His work for both his master’s and Ph.D. degrees included the development of hardware and software for the control and image processing needed for a special purpose high resolution computerized tomography (CT) scanner, which was built to characterize bone structure and bone quality.

Annette M. Schmid

Annette M. Schmid

Medical Director, Head of Oncology Strategy


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Annette M. Schmid, Ph.D.

Development Area: Medical Imaging
Lead Therapeutic Area(s): Oncology and Hematology
Geographic Responsibility: North and South America

Annette M. Schmid, Ph.D., is a medical director and head of oncology strategy for PAREXEL Informatics. Annette is involved in industry wide organizations such as Quantitative Imaging Biomarkers Alliance (QIBA), on the steering committee, FDG-PET (fluorodeoxyglucose -positron emission tomography), on the technical committee and Pharmaceutical Imaging Network for Therapeutics and Diagnostics (PINTAD, co-chair). She provides medical and imaging expertise to internal PAREXEL teams and consults with clients. Dr. Schmid has lead numerous trainings, webinars and discussions on a variety of assessment criteria, including modified RECIST (mRECIST) for liver cancer (HCC), "standard" response evaluation criteria in solid tumors (RECIST), prostate cancer working group 2 (PCWG2), immune-related response criteria (irRC), European Organization for Research and Treatment of Cancer (EORTC) and PET response criteria in solid tumors (PERCIST)for positron emission tomography (PET). While at PAREXEL, Annette has spent the majority of her time working on trials in the field of oncology but she also has experience supporting studies in the musculoskeletal, cardiovascular and neurology field.

Work Experience

Before joining PAREXEL, Annette spent 10 years in academia and research at the Institute of Neurology in London, UK, Boston University (Department of Bioengineering), Massachusetts General Hospital (Harvard Medical School) and in the capacity of research assistant professor at Tufts University (Department of Psychology). During those years, her research and teaching concentrated on imaging modalities ranging from functional, structural and micro-imaging in magnetic resonance imaging (MRI) to electroencephalography (EEG), magnetoencephalography (MEG), PET and various microscopic and radioisotope labelling techniques. Annette focused most of her research on the field of neuroscience along with improving and integrating various imaging techniques for basic research and clinical trials (specifically Parkinson’s disease and Huntington’s disease).

Education

Annette received her Ph.D. in Cell and Developmental Biology from London University, QMW, London UK in 1999. She achieved her undergraduate degrees from the London University, QMW, London UK and Fachhochschule des Bundes, Bonn, Germany.

Oliver Bohnsack

Sr. Director, Medical Affairs


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Oliver Bohnsack, M.D., Ph.D., MBA

Development Area: Medical Imaging
Lead therapeutic Area(s): Oncology, Hematology
Geographic Responsibility: Global

Oliver is the senior director of medical affairs. Based in Berlin, Germany, he is also the head of Oncology and medical relations for Europe. Oliver has significant experience in leading and managing the imaging component of multiple oncology clinical trials. He has developed numerous imaging charters for these studies with various indications and various complexities, in Phases II and III with and without regulatory submission.

Work Experience

Oliver is a board-certified radiologist with broad clinical radiology experience, gathered at various hospitals in Germany and the United States. Following his career in Diagnostic and Interventional Radiology and before joining PAREXEL in 2003, he served as a consultant to the CRO industry and held positions with Siemens Medical Solutions as product manager and later manager for customer training and education.

Education

Oliver received his medical degree in internal medicine, radiology and surgery from the University of Essen. He finished his diagnostic radiology residency in Germany, as well. He earned his MBA in health care management from the University of California, Irvine and his Ph.D. in radiology from the University of Munich.

Rohit Sood

Rohit Sood

Sr. Medical Director, Head of Advanced Imaging


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Rohit Sood

Development Area: Medical Imaging
Lead Therapeutic Area(s): CNS, GI, and Respiratory
Geographic Responsibility: Global   

Dr. Sood is a Radiologist with a strong background in medical imaging research and applications. At PAREXEL, in the role of a medical director and head of Neurology, Respiratory, and Gastrointestinal imaging, he has contributed as a medical lead on more than 60 imaging clinical trials spanning the entire spectrum, from early to late phase.

In the CNS space, he has contributed to CNS science on several Alzheimer’s (AD) clinical trials and worked with our study sponsors to develop criteria for evaluating the eligibility, efficacy and safety aspects of their studies. In the neuro-oncology space, he has the medical expertise and experience on the application of Macdonald, RANO, RANO-BM and iRANO criteria to glioma and CNS metastasis trials. As a medical lead on several multiple sclerosis studies, he has worked with study sponsors to optimally apply the revised McDonald criteria to MS trials. On some MS studies, he is collaborating with our study sponsors on identifying exploratory endpoints using advanced MR methods such as Diffusion Tensor/Spectrum Imaging (DTI/DSI) and Magnetization Transfer Imaging. In addition, he has worked with our sponsors to develop criteria for CNS safety assessments in oncology trials. He has published extensively in the CNS space in peer reviewed scientific journals and has presented at various CNS conferences.   

Additionally, beyond the CNS space, Dr. Sood is celebrated in the respiratory space for his involvement in Idiopathic Pulmonary Fibrosis trials and support of improving the ATS/ERS criteria and has been published in the ATS Journals and Lancet. He also has significant experience providing scientific expertise in GI trials using complicated endoscopies.

Work Experience   

Prior moving to PAREXEL, Dr. Sood served as the Director of MRI research program at the UNM’s BRaIN center, with special interest in development of imaging biomarkers for application to translational research. During this time, he was successful in acquiring funding for clinical and pre-clinical translational imaging research projects, both from the NIH and several large pharmaceutical companies. 

Education   

After completing his masters in electrical engineering (special focus: signal and image processing) and clinical training, he decided to pursue Radiological sciences research at University of Cambridge, England. As part of his doctoral program, he specialized in MR applications development. During his Radiology fellowship at Stanford, Dr. Sood worked on the application of diffusion and perfusion weighted imaging to stroke in a clinical and pre-clinical setup and the application of DCE-MRI to investigating breakdown of the BBB in neurological disorders such as stroke and dementia.