In response to FDA guidance and growing requests from other regulatory agencies that place new emphasis on assessing and minimizing cardiovascular risk, WCC has developed a comprehensive and easy-to-use solution for cost-effective, Blinded Independent Central Review (BICR) of adverse events (AEs) using the Medical Dictionary for Regulatory Activities (MedDRA) and other safety coding dictionaries. WCC’s new service offering builds upon the company’s extensive Endpoint Assessment Committee (EAC) services and employs its WorldPRO^® image management platform to capture, quantify and consolidate virtually any type of clinical data for interpretation by sub-specialty trained experts.

“We’re excited to introduce the first of several new services we’ll be offering to sponsors in the coming months,” said Richard Walovitch, PhD, president of WorldCare Clinical, LLC. “Through our long-standing strategic relationship with Massachusetts General Hospital (MGH), we’re able to deliver the most accurate assessments by providing access to leading clinical experts to meet each trial’s specific protocol requirements. This combined with our proprietary digital portal, WorldPRO, provides the ability to streamline the BICR process and highlights the flexibility of our capabilities.”

WCC’s new service offering for cardiovascular endpoint committees consists of the following:

• Upload of narratives and clinical data by sponsor/CRO via WorldPRO;
• The ability for sites to upload imaging and other supportive information for review and analysis, if applicable;
• Review of consolidated subject data by external MD to confirm need for assessment and complete QC;
• Organization of data into an easy-to-access format for FDA audit.

The WorldPRO system can be accessed by multiple clinical scientists at different locations to collate potential Events of Interest (EoIs) for internal or external review. Equipped with a smart work queue and automated adjudication workflow, WorldPRO allows clinicians to review data efficiently to further expedite the review process. Additionally, WCC has included a standardized scoring system to assess the degree of certainty of the EoI. This unique feature enables WCC to better determine variance in AE coding between independent reviews, while maintaining training and testing programs that maximize the precision and accuracy of a clinical trial.

For more information about WCC’s new service offering, visit: http://www.wcclinical.com/what-we-do/special-services/cardiovascular-endpoint-committee-services.

About WorldCare Clinical

WorldCare Clinical (WCC) is a leading imaging CRO that employs imaging expertise, innovative technology and operational excellence to maximize the precision and accuracy of a blinded independent central review of clinical trial data. Originally founded in 1992 by the Massachusetts General Hospital (MGH) Department of Radiology, WCC has evolved as an independent company while maintaining a strategic relationship with MGH.  With a 20-year focus on imaging trials and their specific requirements, WCC provides sponsors with extensive medical, operational, and image management expertise in support of even the most complex study designs. For more information, visit www.wcclinical.com.

For more information, contact:

Bree Bolognese

SVM Public Relations

(760) 754-7025

bree.bolognese@svmpr.com

WCC President Richard Walovitch, PhD, Associate Director of Biostatistics and Data Management Vincent J.  Girardi III and Director of Regulatory Affairs John Tomera, PhD, discuss how partnering with CROs and using a blinded independent central review can increase trial success.

January 11, 2012

The Foundation for the National Institutes of Health (FNIH)  Biomarkers Consortium has released biomarker data from  studies intended to improve the ability to diagnose and measure the  progression of Alzheimer’s disease (AD).

Researchers used proteomics to  identify biomarkers for Alzheimer’s disease using cerebrospinal fluid  (CSF) samples provided by the Alzheimer’s Disease Neuroimaging  Initiative (ADNI). As with all ADNI data, these have been made openly available  to the global research community. This Biomarkers Consortium study, “Use of Targeted Multiplex  Proteomic Strategies to Identify CSF-Based Biomarkers in Alzheimer’s  Disease,” represents the second part of a two-phased effort using  samples collected by ADNI to qualify biomarker panels in both plasma and  CSF to diagnose and monitor disease progression in people with  Alzheimer’s.

This study was conducted by a team of researchers from  academia, pharmaceutical companies, the National Institutes of Health  (NIH) and the FDA under the auspices of  the FNIH Biomarkers Consortium, a Bethesda, Md.-based public-private partnership that seeks  to develop biomarkers to expedite the diagnosis and treatment of major  diseases. Additional studies utilizing ADNI CSF samples are also  underway as part of this project.

Launched in 2004, ADNI is a multi-million dollar  study aimed at defining the subtle changes that may take place in the  brains of older people many years before overt AD symptoms appear. It is led by the National Institute on Aging at  NIH, through a grant to the nonprofit Northern California Institute for  Research and Education, with private sector support from organizations provided through the FNIH. The study uses  imaging and biomarkers to identify changes taking place in the brains  of older people with normal cognition, mild cognitive impairment (MCI,  which often leads to Alzheimer’s) and Alzheimer’s dementia. A renewal  of the ADNI effort (ADNI 2) was announced in October 2010 by the FNIH  and the NIA, which will continue ADNI for an additional five years  through late 2015.

In addition to the NIH and FDA, participating and funding  organizations include Alzheimer’s Drug Discovery Foundation, Eisai, Eli Lilly, Janssen Alzheimer Immunotherapy Research  & Development, Merck, Pfizer and Takeda Global  Research and Development Center.

http://www.healthimaging.com/index.php?option=com_articles&view=article&id=31096:nihs-biomarker-consortium-releases-study-data-on-alzheimers

November 23, 2011

Prana Biotechnology has secured approval from the Austin Health Research
Ethics Committee to commence a 12 month Phase II Imaging trial evaluating its
PBT2 drug for Alzheimer’s disease.

The double blind, placebo controlled trial will enroll 40 patients with
prodromal or mild Alzheimer’s disease to measure physical changes in the brains
of patients treated with PBT2 for 12 months and evaluate the effects of PBT2 on
patients’ cognition reported in the earlier trial.

The 12-month trial is based on the success of an earlier Phase IIa clinical
trial of PBT2 that showed an improvement in cognition.

Prana executive chairman Geoffrey Kempler said the earlier 12-week trial
reported an improvement in cognition and change in Abeta levels in spinal
fluid.

”We believe that in this 12 month trial PBT2 will establish its credentials
as a safe and effective treatment for Alzheimer’s Disease,” Kempler added.

http://clinicaltrials.pharmaceutical-business-review.com/news/prana-earns-approval-to-begin-alzheimers-drug-trial-231111

By Susan Jeffrey

October 31, 2011

Results of a phase 2 trial of ocrelizumab treatment in patients with relapsing-remitting multiple sclerosis (MS) show that both doses studied significantly reduced the total number of gadolinium-enhancing lesions on magnetic resonance imaging (MRI) at 24 weeks vs placebo.

Both the 600-mg and 2000-mg doses studied reduced clinical relapses, with no apparent separation between doses, and extension data in this report out to 48 weeks suggested sustained efficacy, the researchers note.

“The similarly pronounced effects of B-cell depletion with both ocrelizumab doses on MRI and relapse-related outcomes support a role for B-cells in disease pathogenesis and warrant further assessment in large, long-term trials,” the researchers, with first author Ludwig Kappos, MD, from University Hospital, Basel, Switzerland, conclude.

The results were published online November 1 in The Lancet.

The primary analysis of this study at 24 weeks was presented at the 26th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden, in October 2010, and reported by Medscape Medical News at that time. Data to 72 weeks were presented at the 21st Meeting of the European Neurological Society, and most recently, results out to 96 weeks were presented at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS) in Amsterdam, the Netherlands.

The reduction in clinical relapses seen with treatment was maintained from week 24 to week 96, with subsequent infusions at 24-week intervals. In addition, patients who switched from placebo to ocrelizumab at the end of the blinded phase of the trial had similar reductions in the clinical measures of disease.

“Phase 3 has started; we are recruiting in 1 study for primary progressive [MS] and 2 studies…for relapsing forms of [MS],” David Leppert, MD, who is also from University Hospitals Basel, and F. Hoffman-La Roche Ltd, and who presented the results at ECTRIMS/ACTRIMS, told Medscape Medical News.

The phase 3 program, called ORCHESTRA, includes the 2 relapsing-remitting MS trials, called OPERA I and II, and the primary progressive MS trial, called ORATORIO.

Humanized Antibody

There is increasing evidence that B-cells play a role in the pathogenesis of MS through antibody-dependent and antibody-independent mechanisms, the authors note. Rituximab, an anti-CD20 monoclonal antibody that selectively reduces CD20-positive B-cells, showed “proof of concept” efficacy in MS in phase 1 and 2 investigations. Ocrelizumab is a recombinant humanized version of rituximab meant to provide some advantages in potency, tolerability, and safety for the long term.

In May 2010, the companies stopped a phase 3 program of ocrelizumab in rheumatoid arthritis because of safety issues in that generally older population, including serious infections (some of which were fatal) and opportunistic infections.

In MS, however, results of this phase 2 investigation of ocrelizumab were positive.

The study included 220 patients with relapsing-remitting MS who, for the main analysis, were randomly assigned 1:1:1:1 to receive intravenous ocrelizumab on days 1 and 15, for a total dose of 600 mg or 2000 mg; placebo; or open-label weekly interferon-beta-1a in a dose of 30 μg, given intramuscularly. All groups were double blinded except the patients in the interferon beta-1a group, who were rater masked, the researchers note.

A total of 218 (99%) of the 220 patients received at least 1 dose of ocrelizumab. Of these, 204 patients (93%) completed 24 weeks of the study, and 196 (89%) completed 48 weeks.

On the primary endpoint of the study at week 24, intention-to-treat analysis showed that both doses of ocrelizumab displayed a significant reduction in gadolinium-enhancing T1 lesions, with 89% (95% confidence interval [CI], 68% – 97%; P < .0001) and 96% (95% CI, 89% – 99%; P < .0001) relative reductions over placebo, respectively, for the 600- and 2000-mg doses. Reductions of 80% and 73% in the annualized relapse rates, respectively, also were seen.

In exploratory analyses, both the 600-mg and the 2000-mg ocrelizumab groups were better than interferon beta-1a for the reduction of gadolinium-enhancing lesions.

“We noted serious adverse events in 2 of 54 (4%; 95% CI 3.0 – 4.4) patients in the placebo group, 1 of 55 (2%; 1.3 – 2.3) in the 600 mg ocrelizumab group, 3 of 55 (5%; 4.6 – 6.3) in the 2000 mg group, and 2 of 54 (4%; 3.0 – 4.4) in the interferon beta-1a group,” the authors write.

Week 96 Results

Since these newly published data were first reported, further extension data on ocrelizumab have become available. At week 24, the end of the primary analysis, patients in the initial placebo group, the 600-mg ocrelizumab group, and the interferon beta-1a groups received ocrelizumab 600 mg; participants in the 2000-mg group received 1000 mg, but were switched to 600 mg at week 72.

At weeks 24, 48, and 72, all patients were treated with ocrelizumab. A total of 183 patients completed the week 96 treatment. Dr. Kappos and colleagues reported that during weeks 0 to 96, the annualized relapse rates were 0.18 (95% CI, 0.11 – 0.31) and 0.22 (95% CI, 0.13 – 0.35) for those initially receiving the 600- and 2000-mg doses, respectively, in the original trial.

In these groups, 67.3% and 76.4%, respectively, had no relapses and no confirmed progression on the Expanded Disability Status Scale during the 96 weeks, and 78.2% and 80.0%, respectively, were relapse-free.

Remarkably, at week 96 there were no new gadolinium-enhancing T1 lesions, indicating acute disease activity, in any group, and very few T2 lesions, indicating permanent damage. In the group first given the 2000-mg dose, 1 patient had 1 newly enlarging T2 lesion, and 1 had 2 new lesions at 96 weeks.

In terms of safety, the authors report there was no imbalance in the total number of serious adverse events across all groups over the course of 96 weeks.

Serious infection rates were similar for the groups first treated with ocrelizumab, at 1.97 (95% CI, 0.49 – 7.98) and 1.93 (95% CI, 0.48 – 7.71) events/100 patient-years, and did not increase with ocrelizumab retreatment. Infusion-related reactions were more common after the first infusion, but decreased to placebo levels in subsequent infusions.

The most serious adverse event remains the death of a patient in the 2000-mg group at week 14, the authors point out, “as a consequence of complicated systemic inflammatory response syndrome and a prolonged hospital course.”

There have been no further such safety issues out to 96 weeks, however, including no cases to date of progressive multifocal leukoencephalopathy.

“Our findings show that ocrelizumab rapidly suppresses inflammatory activity as depicted by contrast enhancing lesions in frequent MRIs, and by clinical relapses,” the authors conclude in the current Lancet report. “With caution needed when results are compared between different trials, the effect size in our study on MRI and relapse activity compares favorably with established treatments, and to most of the other compounds in development. In the observation period of 48 weeks, this rapid and pronounced effect was associated with a benign safety profile.”

A “Difficult Equation”

In a linked commentary, Jeremy Chataway, PhD, from the National Hospital for Neurology and Neurosurgery, University College London Hospitals National Health Service Foundation Trust and Imperial College London, United Kingdom, and Professor David Miller, MD, from the National Hospital for Neurology and Neurosurgery, University College London Hospitals National Health Service Foundation Trust and Institute of Neurology, also at University College London, discuss issues surrounding powerful immunological drugs such as ocrelizumab and others now in development.

“The therapeutic successes so far in [MS] should be celebrated, and provide detailed mechanistic insights into an enigmatic disease that affects more than 1 million people worldwide,” they write. “However, perhaps not surprisingly with powerful immunological drugs, serious adverse events have been noted.”

Progressive multifocal leukoencephalopathy, for example, is an “unwelcome intruder” in the phase 4 study of natalizumab, they note. The current overall risk is about 1.5 per 1000 and is affected by length of exposure, John Cunningham virus seropositivity, and previous immunosuppression. For fingolimod, the first oral agent approved for MS, cardiac bradyarrthymias, macular edema, and fatal herpes infection possibly resulting from past steroid use have emerged, they write. For alemtuzumab, issues have been seen with idiopathic thrombocytopenic purpura, Goodpasture’s syndrome, and thyroid dysfunction.

The success of the oral agent cladribine, with a 60% reduction in annualized relapse rate, they point out, was not enough to convince the US Food and Drug Administration or European Medicines Agency to grant licenses because of safety concerns, including an increased rate of herpes zoster and perhaps malignancy, they add. Now, findings from the current study “show the unusual event of a systemic inflammatory response syndrome, resulting in the death of one patient — the association with ocrelizumab remains unclear.”

“For new drugs that are highly effective for prevention of relapses but that are also more risky, what should be done when phase 3 studies that typically last for 2 years are completed (which has yet to happen for ocrelizumab) and the drugs receive regulatory approval?” Dr. Chataway and Dr. Miller ask. MS is a disease of relatively young people who can expect to be treated for 20 years before secondary progression begins, the main cause of long-term disability that occurs after inflammation subsides and progressive axonal damage becomes evident.

It is not clear whether these drugs should be used very early and aggressively in clinically isolated syndrome or early relapsing-remitting MS to completely abolish the inflammation, or with gradual escalation, depending on individual disease activity, they add.

“Therapeutic potency will have to be balanced against early or late risk, both known and unknown. The equation is difficult to solve.”

The study was supported by F. Hoffman-La Roche Ltd and Biogen Idec Inc. Dr. Kappos reports he has received grant support through the University Hospital Basel from Acorda Therapeutics, Actelion Pharmaceuticals Ltd, Advancell, Allozyne, Barofold, Bayer Health Care Pharmaceuticals, Bayer Schering Pharma, Bayhill, Biogen Idec, BioMarin, Boehringer Ingelheim, CSL Behring, Geneuro, Genmab, GlaxoSmithKline, Glenmark, Merck Serono, MediciNova, Novartis, sanofi-aventis, Santhera Pharmaceuticals, Shire Plc, Roche, Teva, UCB, Wyeth, the Swiss MS Society, the Swiss National Research Foundation, Europen Union, Gianni Rubato, Roche, and Novartis Foundations. Disclosures for coauthors appear in the article. Dr. Chataway reports he has been an investigator in clinical trials sponsored by Novartis, Teva, and Biogen. Dr. Miller reports he has received honoraria from Biogen Idec, Novartis, GlaxoSmithKline, and Bayer Schering, as well as research grant support for doing MRI analysis in MS trials sponsored by GlaxoSmithKline, Biogen Idec, and Novartis.

http://www.medscape.com/viewarticle/752659

Susan Jeffrey

October 26, 2011

Top-line results of a second phase 3 trial of oral BG-12 (dimethyl fumarate, Biogen Idec) in relapsing-remitting multiple sclerosis (MS) show that the drug significantly reduced annualized relapse rates vs placebo and compared favorably to a reference group treated with glatiramer acetate (Copaxone, Teva Pharmaceuticals).

Results of the Comparator and an Oral Fumarate in RRMS (CONFIRM) trial, released today by Biogen Idec, showed that the still-investigational oral drug met the study’s primary endpoint, significantly reducing the annualized relapse rate by 44% for the twice-daily dose (P < .0001) and by 51% for the 3-times daily dose (P < .0001) vs placebo at 2 years.

A reference group of patients receiving glatiramer acetate, a treatment already approved for MS, showed that drug reduced the relapse rate by 29% (P < .02) at 2 years, again vs placebo.

Principal investigator of the CONFIRM trial, Robert J. Fox, MD, neurologist and medical director of the Mellen Center for MS at the Cleveland Clinic, Ohio, said he was pleased with the results.

“We need therapies for the relapsing stage of MS that are effective, and tolerated, and have an acceptable route of administration for patients like orals, and I think this drug fits that very well,” Dr. Fox told Medscape Medical News.

“These results confirm what was seen in the previous trial, the DEFINE trial, and show a robust reduction in clinical relapses and MRI measures of disease activity,” he said. “It has a very reasonable safety profile, so it seems like this is going to be a very useful therapy in our armamentarium for relapsing MS.”

In fact, he feels it may even be a candidate for use as a first-line agent. “Given what we see with the efficacy, and a very favorable safety profile that to me measures up as well [as] or better than our current therapies, I don’t see any reason that this couldn’t be considered a first-line therapy for MS.”

The results come hard on the heels of full disclosure of data from the Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS (DEFINE) trial, another phase 3 trial of BG-12, released at the 5th Joint Triennial Congress of the European and Americas Committees for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), and reported byMedscape Medical News at that time. Top-line results from the study were released in April.

“We conclude that these results may provide a therapeutic option for patients with relapsing MS, with robust efficacy, a good tolerability, and excellent safety profile for this oral drug,” DEFINE principal investigator Ralf Gold, MD, professor and chair, Department of Neurology, St. Josef-Hospital/Ruhr-University, Bochum, Germany, concluded at the meeting, which was held in Amsterdam.

Both studies were funded by Biogen Idec.

DEFINE and CONFIRM

BG-12 is believed to have dual anti-inflammatory and neuroprotective effects via the Nrf2 pathway. In a phase 2b trial, it reduced inflammatory activity in patients with relapsing-remitting MS. BG-12 received fast track designation from the US Food and Drug Administration in 2008.

The CONFIRM clinical trial was a phase 3, global, randomized, double-blind, placebo-controlled, dose-comparison study to determine the efficacy and safety of BG-12. It enrolled 1430 people with relapsing MS.

The study looked at 2 dose regimens of BG-12 (240 mg twice a day [BID] and 240 mg 3 times a day [TID]), as well as a reference comparator of glatiramer acetate at a dose of 20 mg daily given subcutaneously. Both BG-12 and glatiramer acetate groups were evaluated vs placebo.

In addition to significantly reducing the primary endpoint of acute relapse rates at 2 years, BG-12 met all secondary relapse and magnetic resonance imaging endpoints for both dose regimens, the company notes. Results for the BG-12 and glatiramer acetate treatment groups at 2 years compared with placebo included:

• BG-12 reduced the number of new or newly enlarging T2-hyperintense lesions by 71% for BID (P < .0001) and by 73% for TID (P < .0001) vs placebo; there was a 54% reduction for glatiramer acetate vs placebo (P< .0001).
• BG-12 reduced new T1-hypointense lesions by 57% for BID (P < .0001) and by 65% for TID (P < .0001) vs placebo; the reduction was 41% with glatiramer acetate vs placebo (P < .003).
• BG-12 reduced the proportion of patients who relapsed by 34% for BID (P < .003) and by 45% for TID (P < .0001) vs placebo; the reduction was 29% with glatiramer acetate vs placebo (P < .01).

Initial results showed that BG-12 reduced 12-week confirmed disability progression, as measured by the Expanded Disability Status Scale, by 21% for BID and 24% for TID at 2 years compared with placebo vs 7% with glatiramer acetate.

Although these latter effects of disability were not statistically significant, they may be attributable to the unexpectedly low rate of disease progression in the placebo group, which was approximately half of what has been seen in clinical trials of approved and experimental MS therapies, including the rate seen in DEFINE, Doug Williams, PhD, Biogen Idec’s executive vice president of research and development said during a conference call this morning.

“Further analyses of this endpoint are underway,” he added. They still plan nevertheless to file for a claim on reduction of disability based on these data in combination with DEFINE, company executives noted.

Dr. Fox acknowledged that the lack of effect on disability was a disappointing aspect of the trial. “Certainly we need to look further at the data to understand why that is,” he said. “Clearly the trend was in the right direction but the statistical significance was not met.”

The entry criteria were the same for CONFIRM and DEFINE in terms of recruiting patients with active disease; the only difference was that in CONFIRM, patients could not have been treated previously with glatiramer acetate, which was allowed in DEFINE.

In CONFIRM, both dose regimens of BG-12 showed favorable safety and tolerability profiles, which were similar to those seen in DEFINE, the company notes.

Overall, the incidence of adverse events, serious adverse events including serious infections, and discontinuations resulting from adverse events were similar across all study groups, including placebo. The incidence of hepatic and renal events was also comparable among all study groups.

As in DEFINE, the most common adverse events with BG-12 were flushing and gastrointestinal events. There were no malignancies in the BG-12 groups, the company notes.

“We now have strong positive results for BG-12 in two robust pivotal clinical trials with more than 2,600 patients,” said Doug Williams, PhD, Biogen Idec’s executive vice president of research and development said in a statement. “We are gratified by these strong efficacy and safety results, which, when combined with BG-12′s oral route of administration, position it as a potentially important MS therapy. We are working aggressively to prepare our regulatory submissions with the goal of making BG-12 available to MS patients as quickly as possible.”

The company plans to present detailed data from CONFIRM at an upcoming medical meeting, he noted, “and our filing is on track for the first half of next year.”

In the CONFIRM and DEFINE results, there were some differences between doses on some of the endpoints, Dr. Williams acknowledged.

“I think our conclusion looking across both studies is that both TID and BID provide approximately comparable results,” he said. “We don’t really see that there’s a huge or meaningful difference between the doses based on the aggregate data that we’ve seen, so we think that BID dosing for this drug will be appropriate.”

The DEFINE study was supported by Biogen Idec Inc. Dr. Fox has received consultant fees from Avanir, Biogen Idec, EMD Serono, and Novartis and has received research support from Biogen Idec. Dr. Gold discloses having received honoraria from Bayer Health Care, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience research support from Bayer Health Care, Biogen Idec, Merck Serono, Novartis, and Teva Neuroscience. Several of the authors are employees of the company.

Susan Jeffrey is the news editor for Medscape Neurology & Neurosurgery. Susan has been writing principally for physician audiences for nearly 20 years. Most recently, she was news editor for thekidney.org and also wrote for theheart.org; both of these Web sites have been acquired by WebMD. Prior to that, she spent 10 years covering neurology topics for a Canadian newspaper for physicians. She can be contacted at SJeffrey@webmd.net.

October 19, 2011

Diffusion-weighted MRI patterns can guide the work-up for patients presenting with acute ischemic stroke symptoms, according to a study in the November Journal of Neurology, Neurosurgery & Psychiatry.

University of Pennsylvania researchers led by neurologist Monisha Kumar, MD, performed electrocardiogram, non-contrast head CT, brain MRI, head and neck magnetic resonance angiography (MRA), and transoesophageal echocardiography studies with 273 patients. Stroke neurologists determined TOAST (Trial of Org 10172 in Acute Stroke Treatment) classification on admission and on discharge. If the stroke subtype changed between the initial diagnosis and the diagnosis testing, they considered how CT and MRI figured into that change.

The team found that diffusion-weighted MRI patterns appear to predict the cause of stroke better than conventional methods. Further, they say their data suggest an MRI-based diagnostic algorithm can potentially eliminate the need for echocardiography in one-third of stroke patients and may cut back on the need for secondary extracranial vascular imaging studies.

http://www.diagnosticimaging.com/mri/content/article/113619/1973351

WCC Executive Vice President, Business Development Richard Taranto and President Richard Walovitch, PhD provide an insight into imaging CROs in central and eastern Europe, including guidelines and best practices for standardization of imaging equipment for clinical trials.