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May 6, 2019

Industry Briefs…2

Drug & Device Pipeline News…7Nineteen drugs and devices have entered a new trial phase this week.

JobWatch…8Job listings, networking events and educational programs.

CenterWatchWeekly

By Brandon May

A sponsor chooses a site based on its abil-ity to conduct the research, not on its financial management skills. But poor

money management can sink a trial regardless of how well the site conducts the research.

In today’s budget-conscious environ-ment, sponsors often contract with small- to medium-size sites that may not have the resources or expertise to effectively manage finances. And unless they provide their sites with the necessary support up front, chances are good that the sites will be overwhelmed.

“You’re asking someone who is doing a thousand other things [and] who might not have all of the accounting skills necessary, and you’re placing all of that responsibility on them,” says Christina Kahn, Senior Director, Site

Alliance Management at Frenova Renal Re-search. “What happens is that thousands and thousands of dollars go unpaid,” Kahn says.

Most investigators in small- and medium-size sites don’t have the budget they need to hire support staff, including staff with exper-tise in accounting, points out April Mulroney, Senior Vice President of Accounting and Chief Data Officer at WCG Clinical. “Sites’ strong point is not accounting and finance but the research itself,” Mulroney explains.

Sponsors and CROs don’t always make it easy for sites, she says. “Sponsors don’t always provide the transparency on what payments are for, and sites will receive checks from the sponsor with a lump sum that often doesn’t reference the study or the reference period.”

Equipping Small Sites to Manage Trial Finances: Challenges and Solutions

By John W. Mitchell

Don’t wait for an inspection notice to begin preparations for a regulator’s visit.

Start the trial with a future inspection in mind, says Donna Dorozinsky, founder and CEO of Just in Time GCP. Document all aspects of the trial in the trial master file (TMF) to give an inspector a clear picture of the study. The TMF, Dorozinsky says, is the cornerstone of an inspection.

“If you have a TMF that really tells the story thoroughly and completely, you’re going to have at your disposal all of the in-formation that’s available to allow you to tell the story to the health authority,” she says.

As an example, she cites one trial team that began from the position that their

study was at high probability for an inspec-tion. Throughout the study, they assessed operations, making sure the records were complete, deviations were addressed immediately, all the documentation was organized and all the information was easily retrievable. When the inspection came — the end of the story — they were ready to respond to FDA field investigators’ queries.

“They asked, we provided ... and as we provided, the questions got answered, and there were no findings for the work we did,” she says.

“Straight up, be honest,” Dorozinsky emphasizes. “If [inspectors] don’t have to go hunting, digging and questioning,” they are less likely to think you are hiding something.

Tell Your Study’s Story: Preparing for a Regulatory Inspection

Are your operations measuring up? Benchmark report helps you know how to accelerate trial

growth and maximize e�ciency using current industry trends.

2019 Financial &Operating Benchmarks

COMPARISON OF SMALL AND LARGE SITES, 2018 16

Source: CenterWatch 2019 Financial & Operating Benchmark Survey

In the previous year, how long did it typically take for Sponsors and CROs to pay your?deciovni neeb dah taht krow rof etis evitagitsevni

Sponsor/CRO Payment Frequency

> 120 days

90–120 days

60–90 days

45–60 days

30–45 days

Large Sites(n=86)

12%

20%

26%

26%

16%

Small Sites(n=79)

3%10%

41%

26%

18%

COMPARISON OF SMALL AND LARGE SITES, 2018 21

Sponsor/CRO Improvement Areas

Source: CenterWatch 2019 Financial & Operating Benchmark Survey

In what areas would you most like to see improvement in your relationships with Sponsors and CROs?

% mentioning

2018 Large Sites 2018 Small Sites 2018 Aggregate 2016 Aggregate(n=86) (n=79) (n=165) (n=257)

Contract and budget negotiation issues 37% 25% 31% 14%

* %41 %41 %41 senilemit raelc fo noitaerC

Establishment of clear roles and responsibilities 11% 11% 11% 7%

%9 %8 %01 %8 ygolonhcet elbaliava fo esU

* %1 %0 %1 skcabdloh evomeR

Payment turnaround and well-skilled monitors 1% 0% 1% 7%

* %1 %0 %1 stnemeergA retsaM lanoitiddA

%7 %1 %0 %1 segnahc oN

* Data not collected in 2016 survey.

COMPARISON OF SMALL AND LARGE SITES, 2018 18

Greatest Causes of Delays

Source: CenterWatch 2019 Financial & Operating Benchmark Survey

sti gnimrofrep ni etis ruoy ot syaled esuac saera gniwollof eht fo hcae od yltneuqerf woHresponsibilities?

IRB committee review & approval

Enrolling study volunteers

Protocol amendments from the sponsor

Delayed payment from sponsors

Sponsor/CRO responsiveness to inquiries

Contract negotiation & approval

Budget negotiation & approval 64%46%

47%

45%

42%

29%

29%

% indicating ‘always’ or ‘frequently’

Regulatory compliance process

Screening study volunteers

Large Sites (n=86)Small Sites (n=79)

Responding to queries in CRF

24%

24%

23%

Clinical trial drug availability

Retaining study volunteers

Review of ICD with patient

17%

8%

8%

59%42%

25%

21%

15%

17%

10%

28%

8%

8%

7%

45%

27%

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PipelineNews

FDA Actions

Company name Drug name Indication FDA action

Lumendi, LLC DiLumen C2 second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment

510(k) clearance granted

Varian Calypso Anchored Beacon transponder

tumor detection 510(k) clearance granted

Conavi TM Medical Inc. Novasight Hybrid System simultaneous imaging of coronary arteries with both intravascular ultrasound (VUS) and Optical Coherence Tomography (OCT)

510(k) clearance granted

Prisyna, the oral care division of Synedgen

Moisyn product line xerostomia 510(k) clearance granted

C4 Imaging LLC HDR MRI Marker use prior to high dose rate (HDR) brachytherapy to accurately locate the position of the applicators that guide the placement of radioactive sources for the treatment of multiple cancers

510(k) clearance granted

Amerigen Pharmaceuticals Limited and Dipharma S.A.

Miglustat 100 mg capsules Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option

aNDA � led

Sage Therapeutics intravenous formulation of brexanolone (SAGE-547)

postpartum depression (PPD) NDA � led

Veloxis Pharmaceuticals A/S

de novo indication of ENVARSUS XR (tacrolimus extended-release tablets)

Prophylaxis of organ rejection in kidney transplant patients

sNDA � led

Jazz Pharmaceuticals Xyrem (sodium oxybate) oral solution

cataplexy and Excessive Daytime Sleepiness (EDS) in pediatric narcolepsy patients

sNDA � led

Abeona Therapeutics Inc. ABO-102 AAV-mediated gene therapy for the treatment of San� lippo syndrome Type A (MPS IIIA)

RMAT Designation granted

Immusoft Corporation Immune System Programming MPS I (Mucopolysaccharidosis type I) Orphan Drug Designation granted

Stealth Biotherapeutics elamipretide Leber’s hereditary optic neuropathy (LHON) Orphan Drug Designation granted

P� zer Inc. TRUMENBA (Meningococcal Group B Vaccine)

Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years

Breakthrough Therapy Designation granted

MeiraGTx Limited AAV-RPGR X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene

Fast Track Designation granted

The following is a sampling of FDA regulatory actions taken during the previous month, compiled from CenterWatch and third-party sources including the FDA and company press releases. For more information on FDA approvals, visit www.centerwatch.com/drug-information/fda-approvals/.For custom drug intelligence reports, email marketresearch@centerwatch.com. Join the LinkedIn Drug Research Updates group!

9:45 AMiPad3

Addressing Barriersto Entry and Retention

By Sony Salzman

B eing a principal investigator (PI) is tough. So tough, in fact, that more than half of new investigators give up er

thei rst FDA-regulated drug trial.Studies by the T s Center for the Study of

Drug Development (CSDD) have revealed a variety of challenges for rst-time investigators.

e rst — and some would say worst — challenge is that the path to success for PIs is murky, said Gerrit Hamre, project manager of CTTI and co-author of the group’s paper on the study. Although there are training programs and resources for investigators, most new investigators are unaware of their existence (outside of GCP training), and un-derestimate the infrastructure, st ng, bud-geting, contracting, and operational skills necessary to succeed.

e second overwhelming obstacle for edgling investigators is administra-

tive burden. Complex protocols, rigorous reporting demands and multiple technol-ogy platforms place a huge strain on inves-tigators and sta .

e third major obstacle new PIs face is the lack of accolades and/or s cient nancial reward to make all of that e ort worthwhile.

With mounting evidence that the prob-lem isn’t getting better, sponsors and CROs are rethinking the site selection process and trying to develop new ways to support inex-perienced investigators.

Sponsors and CROs are doubling-down on their top-performing sites — a trend that has helped fuel industry consolidation, says Ken Getz, director and associate professor of CSDD.

“At the same time that sponsors are look-ing for scaled, experienced sites and site networks, the CROs are buying them,” said Getz.

He predicts that in the short term, the in-dustry will continue to see the largest and most expensive sites and site networks build more share of the market.

Yet sponsors can’t rely solely on vetted academic medical centers and large com-mercial sites for all of their study partici-pants; the burgeoning elds of rare disease and oncology research in particular require them to cast a wider net for patients.

Experts agree that rst time investiga-tors can take some steps to bolster success — including nding a mentor, hiring an ex-perienced research coordinator, learning to budget appropriately and being technologi-cally savvy and platform-agnostic — but most also agree that ultimately, sponsors and CROs need to step up if they want their PIs to thrive.

“I’m sympathetic to investigators because you don’t know what you’re getting into,” says Hamre, adding, “I do think investiga-tors very en bite o more they can chew, but they don’t realize it. In that regard, I think it’s the sponsors and the CROs that have a bit more responsibility.”

Getz added that sponsors must “take ownership for site selection practices that

Industry Tries to Stem Investigator Dropout

© 2018 CenterWatch. Duplication or sharing of this publication is strictly prohibited.

CRA/CRC Shortages Slow Clinical Trial Pace

June 2018 A CenterWatch Publication Volume 25, Issue 06

see CRA/CRC on page 8

Industry DevelopingStandardized TrainingBy Daphne Butas

As clinical trials continue to change, the evolving roles of CRAs and CRCs are exacerbating the problems sponsors and

CRO nding well-trained candidates.“What’s going to really get interesting is how

much these roles are going to evolve as more new initiatives come forward, like eConsent,

ePRO and risk-based monitoring,” said Jim Kremidas, executive director of the Association of Clinical Research Professionals (ACRP). As risk-based monitoring has taken hold and more monitors are analyzing data from a central loca-tion rather than traveling to the sites, sponsors and CROs are looking for CRCs with more of a robust math background, he said. And as the sponsors’ and CROs’ relationships with sites becomes ever more important, sponsors and CROs are looking for CRAs who excel at forg-ing friendly, supportive connections with sites.

“I think we’re going to see a morphing of these role into subspecialties — a data analyst and site-relationship manager type of CRA, along with the traditional role that the CRA has always had,” said Kremidas. “With CRCs, I think we’ll begin to see a quality assurance focus, someone who oversees the input of the data into the eCRFs. I think we’ll see a tech-nology type of specialist for patients to call in order to get help logging on. And I think the traditional role will be there, too.”

see Investigator Dropout on page 6

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9:45 AMiPad3

Clinical Research of WestFloriday, Inc.

Therapeutic AreasTherapeutic Areas

Cardiology/Vascular DiseasesDermatologyDevicesEndocrinologyGastroenterologyHealthy VolunteersImmunologyInfections and Infectious DiseasesInternal MedicineMusculoskeletalNeurologyObstetrics/Gynecology (Women’s Health)OphthalmologyOrthopedics/Orthopedic SurgeryPharmacology/ToxicologyPsychiatry/PsychologyPulmonary/Respiratory DiseasesRheumatologyUrology

Aydin KeskinerPresidentClinical Research of West Florida, Inc.2147 NE Coachman RoadClearwater, FL 33765-2616USA727-466-0078727-461-7793 (fax)research@crwf.comwww.crwf.comView Map

Contact Center

Currently Enrolling Trials

• Are you a current or former smoker? • Are you one of 5 million living with Lupus? • Crohn's Study • Cutaneous Lupus Study[Show More]

Clinical Research of WestFloriday, Inc.

Therapeutic AreasAydin KeskinerPresidentClinical Research of West Florida, Inc.2147 NE Coachman RoadClearwater, FL 33765-2616USA727-466-0078727-461-7793 (fax)research@crwf.comwww.crwf.comView Map

Contact Center

Clinical Research of West

Customize your page with:• Clinical trial listings for recruitment purposes• List your medical specialties, performance metrics, etc.

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WCG | CWWeekly (ISSN 1528-5731)

Leslie Ramsey Editorial DirectorBill Myers Clinical Trials SpecialistRenee Breau ProductionRussell Titsch Business Development Director

© 2019 CenterWatch. All rights reserved. No part of this publication may be distributed or reproduced in any form or by any means without the express written consent of the publisher.

CenterWatch Main and Editorial Offices 300 N. Washington St., Suite 200, Falls Church, VA 22046 editorial@centerwatch.com / sales@centerwatch.com

Permission requests can be emailed to editorial@centerwatch.com.

Advertising packages and reprints are available:Email Russ.titsch@centerwatch.com or call (703) 538-7651.

WCG | CWWeekly May 6, 2019 2 of 8

Industry Briefs

New Q&A Service Gives Access to Trial ExpertsTrial professionals with questions about research ethics and oversight can turn to a new forum from WCG Clinical.

“Ask the IRB Experts” is a conduit to WCG’s industry authorities Lindsay McNair, chief medical officer; David Forster, chief compli-ance officer; Jeffrey Cooper, vice president of process and strategic improvement; Daniel Kavanaugh, senior scientific advisor, gene therapy; David Borasky, vice president of IRB compliance; Stuart Horowitz, institutions and institutional services head; and Yvonne Higgins, vice president of quality manage-ment for Copernicus Group IRB.

Questions may be submitted anony-mously to the forum, and answers are posted on the WCG Clinical website.

To ask a question of the experts, go to: https://bit.ly/2XAzDTt.

Sharpless Points to Planned Guidance on Non-Opioid TrialsSpeaking at the 2019 Food and Drug Law In-stitute conference last week, acting FDA Com-missioner Ned Sharpless outlined the agency’s priorities this year, including new guidance for the development of non-opioid drugs.

“We are planning updated guidance,” Sharpless said, “outlining the appropriate clinical endpoints and clinical trial approaches for the development of non-opioid drugs for use in the treatment of acute and chronic pain.” He did not indicate a date for releasing the guidance.

Sharpless, a cancer researcher and oncolo-gist for nearly 20 years and former head of the National Cancer Institute, also pledged to stay the course set by his predecessors, saying “I feel up to the task because of the great and stable leadership at the FDA who provide ad-vice, and because of my relevant background.”

FDA Offers Clinical Guidance for Developing ADHD MedsThe FDA has released a draft guidance to guide sponsors developing stimulant drugs

for attention deficit hyperactivity disorder (ADHD), outlining general considerations for trial design, clinical pharmacology and research involving pregnant women.

The guidance suggests several consid-erations for trial design. For example, it’s a good idea for sponsors to include data from adequate studies in pediatric patients in their NDAs, as the disorder begins in child-hood.

A single trial in adult patients can sup-port adult indications, the agency says, be-cause there is a sufficient similarity between the pathophysiology, disease characteristics and treatment outcomes for children and adults.

NDAs also should include data adequate to assess the drug’s safety and effectiveness for patients four years of age and up. Spon-sors should conduct one study in adolescent patients 13 to 17 years of age and one study in patients aged four to 12 to generate evidence of effectiveness.

Safety and effectiveness should be assessed using randomized, double-blind, placebo-controlled, parallel-group design trials, and sponsors should conduct at least one randomized, fixed-dose trial that exam-ines more than one dose.

Many Oncology Approvals Based on Sub-Standard of Care, Study SaysNot all cancer therapies the FDA has ap-proved in the past six years were evaluated against the appropriate standard of care, an independent study says.

Researchers from the Mayo Clinic and Or-egon Health & Science University examined data on 96 cancer drugs approved by the FDA between January 1, 2013, and July 31, 2018, evaluating the strength of the control arms used in the randomized clinical trials (RCT).

They determined that 16 RCTs, 17 percent, relied on suboptimal control arms. Four of the 16 trials omitted active treatments in the con-trol arm by limiting the investigator’s choice of agent, 10 used a control agent known to be inferior to other available agents and two relied on a previously used treatment with a known lack of benefit.

Fifteen of the trials were conducted outside the U.S., according to the study, published last week by the Journal of the American Medical Association Oncology. Two of the drugs were approved under an ac-celerated FDA pathway.

“Although anticancer drug approvals are increasing,” the researchers concluded, “a proportion of these drugs are reaching the market without proven superiority to what is considered the standard of care at the time of patient enrollment in pivotal trials.”

Most European Academic Centers Fail to Report Trials, Study Finds More than four-fifths of European clinical tri-als are not complying with EU transparency laws, an analysis by a group of nonprofits has found.

Researchers at TranspariMED, Buko Pharma-Kampagne, Test Aankoop and

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WCG | CWWeekly May 6, 2019 3 of 8

Industry Briefs

Health Action International analyzed trials run by 30 different universities in Europe and the UK and found that 778 trials were “verifiably missing data” that was supposed to be reported to European regulators. Under European Union rules introduced in July 2014, every clinical trial registered in the EU must post summary results within 12 months of a trial’s completion — or within six months in the case of pediatric trials.

Fourteen universities — located in France, Italy, Norway and Sweden — have failed to post a single clinical trial result, the report shows, and 13 others “perform weakly,” with reporting rates ranging from 2 percent to 33 percent,” the researchers found.

The UK proved to be the bright spot in the study: Oxford University, University College Lon-don and King’s College London all have posted more than 80 percent of their trial results.

Universities in the U.S. are performing better than their EU counterparts, but still lagging in reporting compliance, according to a similar study TranspariMED and Universities Allied for Essential Medicines released last month (Cen-terWatch Weekly, April 1, 2019). One-third of U.S. academic research institutions have failed to comply with FDA reporting rules similar to the EU’s, the report says.

Read the report here: https://bit.ly/2IVS7uy.

Caris Life Sciences Buys Up PharmatechBiotech firm Caris Life Sciences has acquired Pharmatech, an oncology-focused site man-agement organization (SMO) that has devel-oped a way to speed up trial enrollment.

Pharmatech, an originator of the Just-In-Time rapid enrollment system, also brings to the table the largest research-ready oncology net-work, which Caris will use to connect hundreds of cancer research centers across the nation.

Caris’ acquisition is intended to shift the company from a traditional physician outreach model to a real-time approach that takes care of patient identification at the lab. The strategy removes the need for patients to travel to a central trial site by enabling the patient to be enrolled days earlier and stay in the local physician’s care.

Hacker Pilfers Client Data from Charles River LabsA “highly sophisticated, well-resourced” hacker recently made off with some of Charles River Laboratories’ client data, the CRO reported last week.

On April 30, the company informed clients that parts of its information systems were ac-cessed by an unauthorized intruder. Upon no-ticing “unusual activity” in mid-March, Charles River launched an investigation with the help

of federal law enforcement and cybersecurity experts that is still ongoing.

Some client data was taken during the March breach, the CRO said, but it noted that there’s no evidence at this time that the data was deleted, altered or corrupted.

“The number of clients whose data is known to have been copied represents ap-proximately one percent of Charles River’s total number of clients,” the company said.

Medicines Discovery Catapult Launches R&D PlatformIn an effort to improve UK competitiveness in life sciences research, biotech nonprofit Medi-cines Discovery Catapult (MDC) has kicked off its Virtual R&D Discovery Services Platform, which features partnerships with 22 CROs.

The platform offers a matching ser-vice that helps small- and medium-sized enterprises (SMEs) in the UK link up with participating specialist, private-sector CROs to propel drug discovery. It also provides members with tools like comprehensive project reviews, data package assessments and development plan advice.

MDC said that 42 percent of the coun-try’s biotech SMEs consist of fewer than five employees and require connections with outsourced scientific expertise and technology.

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Features

Regulatory Inspectioncontinued from page 1 “A sign of the lack of

preparedness for an inspection is the [organization’s] difficulty in

locating records needed. The lack of an organized system for records leads to additional questions and ultimately increases the time an

investigator is on-site.”

—Eric Pittman, Program Division Director, FDA Office of Bioresearch

Monitoring Operations

That doesn’t mean that there won’t be a finding or a Form 483 issued, she cautions. But a complete TMF will help explain any problems, how they were corrected, how a reoccurrence will be prevented and how the site will assess any corrective action. Such preparedness really speaks to the FDA, Dorozinsky says.

Eric Pittman, Program Division Director of the FDA’s Office of Bioresearch Monitoring Operations, echoes Dorozinsky in his assess-ment of site readiness.

“A sign of the lack of preparedness for an inspection is the [organization’s] difficulty in locating records needed,” Pittman says. “The lack of an organized system for records leads to additional questions and ultimately increases the time an investigator is on-site.”

“It is obvious when we start an in-spection, almost immediately, if a firm is prepared for us,” says Pittman. “Prepared firms will have a plan for what to do when

we arrive, who to call, in general, what to expect.”

Once an inspection is initiated, the TMF should be explained to the inspector, he says. The explanation should include a tour of the documents within the file and what they should/should not expect to find. This is important because that extra few minutes of explanation can significantly reduce the amount of time it takes an investigator to learn the systems.

Trial staff also should be prepared to ask for explanations, Pittman says. “I want industry, in general, to be comfortable ask-ing questions of both the field investigator and FDA management,” he says. “If you don’t understand an investigator’s request, a 483 observation, a discussion point, an action taken by an investigator ... it’s perfectly fine to ask.”

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Features

Manage Trial Financescontinued from page 1 “Payments to sites from sponsors

can be unpredictable depending on the frequency of visits, frequency

of source data verification from monitors and terms stipulated in

the site’s contract.”

—Greg Manning, Business Operations Manager, Suncoast Clinical Research

Additionally, the fact that many sponsors wait 90 days or longer to reimburse sites can place researchers in a bind. “The financial burden this puts on sites is notable, since they’re having to pay their staff, their rent and their electricity all up front,” Mulroney notes. “In a sense, sites are fronting the industry on clinical research. It costs approximately $40,000 just to initiate a site, so if you’re not paying them on time, you’re not enabling them to succeed.” As a result, many sites drop out of clinical trial research.

“Payments to sites from sponsors can be unpredictable depending on the frequency of visits, frequency of source data verifica-tion from monitors and terms stipulated in the site’s contract,” says Greg Manning, Business Operations Manager at Suncoast Clinical Research. “If a site’s ability to operate is dependent on predictable revenue, then the site will need to build up a large operat-ing balance in order to navigate through the leaner payment periods,” Manning says.

While a standard “recipe” for managing an organized clinical trial that hits its financial marks may be helpful, clinical trials vary in complexity and budget requirements. Stan-dards must be tailored to the individual trial; however, studies often perform well when a finalized per-patient budget is established.

The per-patient budget, according to Manning, should align with electronic data capture (EDC) to produce payment. “You also need a mechanism to track revenue from vis-its, items that require invoices, and payments to patients, providers and vendors,” Manning

adds. “This mechanism could be the source document or a visit checklist that is provided to accounting personnel.”

Clearing up payment worries also can in-crease sites’ research effectiveness, Mulroney says.

“Sites would be more focused on research if they didn’t have to spend hours trying to reconcile payments and figure out how much they’re owed,” she says. “They’re diverting their attention and their limited hours on areas that are not actually their sweet spot. Making payments timely is the number-one factor a site will consider when choosing which studies to initiate.”

Accounting technology also may help, Mulroney adds, yet investment in these tech-nologies is tremendously low. “You would be shocked to see how many sponsors and CROs run their accounts payables to sites in an Excel spreadsheet,” she says. “The systems in place don’t talk to each other.” Some of the key systems that need to talk with each other, Mulroney adds, are the EDC, the system that generates the dollar amount that’s been

contributed to the site, and a link into the banking system so payments can be made electronically and seamlessly.

Mulroney believes automation of ac-counts can be helpful, too. “A clinical trial management system should be integrated into [a site’s] activity system so that they’re auto-generating their receivables,” she says. “The whole process needs to be automated in addition to having a member or team that has expertise in accounting.”

According to David Scott, President & CEO of Palm Beach Research, if all sites adhered to strict financial and organizational standards, there would be greater growth of clinical trials because sites would be motivated to continue to pursue research. “Sites would be more equipped to financially survive,” Scott says. “Sites would also recruit more patients at a faster rate, and studies would turn over quicker. Research would only be limited by how quickly new treatment protocols are created by the scientists behind the pharma-ceutical companies, not the failures of poorly prepared research organizations.”

“If all sites would efficiently manage their clinical trials by negotiating for fair and stronger budgets,” Manning says, “manag-ing invoices and being transparent, then the industry could move to a more templated system where budgets represent a true fair market value from the beginning.”

“Sites would be reimbursed more ef-ficiently and automatically, which would keep the focus on patient safety and protocol adherence without the need for complicated financial tracking.”

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Drug & Device Pipeline News

Company Drug/Device Medical Condition Status Sponsor ContactForbius AVID200 myelofibrosis (MF) Phase I trial initiated forbius.comTetra Discovery Partners

BPN14770 early Alzheimer’s disease (AD) Phase II trial initiated enrolling 255 subjects ages 55-85 in 60 sites across the U.S.

tetradiscovery.com

Axovant Gene Therapies, Ltd.

AXO-Lenti-PD Parkinson’s disease Phase II trial initiated enrolling 60 subjects

axovant.com

3-V Biosciences, Inc. TVB-2640 non-alcoholic steatohepatitis (NASH)

Phase II trial initiated enrolling 90 subjects in the U.S. and 25-30 subjects in China

3vbio.com

OMEICOS Therapeutics

OMT-28 persistent atrial fibrillation (AF) Phase II trial initiated enrolling 120 subjects at sites in four European countries

omeicos.com

Exelixis cabozantinib (CABOMETYX) in combination with nivolumab (Opdivo) and ipilimumab (Yervoy) versus nivolumab and ipilimumab

previously untreated advanced renal cell carcinoma (RCC)

Phase III trial initiated enrolling 676 subjects at 150 sites globally

exelixis.com

I-Mab Biopharma and MorphoSys AG

TJ202/MOR202 relapsed or refractory multiple myeloma

Phase III trial initiated enrolling 291 subjects at sites in China and Taiwan

i-mabbiopharma.commorphosys.com

ACADIA Pharmaceuticals, Inc.

pimavanserin major depressive disorder (MDD) Phase III trial initiated enrolling 280 subjects at sites in the U.S.

acadia-pharm.com

CoapTech, LLC PUMA-G System gastrostomy 510(k) clearance granted by the FDA

coaptech.com

Purdue Pharma, L.P. nalmefene hydrochloride (HCl) injection

emergency treatment of known or suspected opioid overdose

Competitive Generic Therapy (CGT) designation granted by the FDA

purduepharma.com

Belite Bio LBS-008 (BPN-14967) atrophic age-related macular degeneration and Stargardt disease

IND approval granted by the FDA

belitebio.com

AVROBIO, Inc. AVR-RD-01 Fabry disease IND approval granted by the FDA

avrobio.com

Finch Therapeutics Group, Inc.

Full-Spectrum Microbiota (FSM)

pediatric Autism Spectrum Disorder (ASD)

Fast Track designation granted by the FDA

finchtherapeutics.com

Bayer darolutamide non-metastatic castration-resistant prostate cancer (nmCRPC)

Priority Review designation granted by the FDA

bayer.us

GlaxoSmithKline Benlysta (belimumab) intravenous (IV) infusion

pediatric systemic lupus erythematosus (SLE)

Priority Review designation granted by the FDA

gsk.com

United Therapeutics Corporation and XVIVO Perfusion, Inc.

XPS and STEEN Solution

ex-vivo lung perfusion (EVLP) PMA approval granted by the FDA

unither.comxvivoperfusion.com

Samsung Bioepis Co., Ltd.

ETICOVO (etanercept-ykro)

rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis

Approval granted by the FDA samsungbioepis.com

Regeneron Pharmaceuticals, Inc. and Sanofi

Praluent (alirocumab) reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease

Approval granted by the FDA regeneron.comsanofi.com

Bausch Health Companies, Inc.

DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%

plaque psoriasis in adults Approval granted by the FDA bauschhealth.com

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