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The 4 Biggest Investigator Site Payment Issues — And How

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Offer Details: Mar 15, 2017 · To top it all off, the employer has decided it is appropriate to hold back 10 percent of all you earn until your last day on the job — whenever that may be. Of course, the employer still expects you to provide your top performance every day and wonders why at some point you no longer want to continue working for them. See more ...

Clinical Technologies

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Offer Details: Dec 09, 2019 · CLINICAL TRIAL TECHNOLOGY SOLUTIONS. Trial insight starts at the source. Deployed independently or as part of a full Lunexis eSource Ecosystem, our convenient, site-based electronic clinical outcome assessment (eCOA) solutions capture and integrate clinician-reported data at the point of care. Supply Accountability is the tracking and ... See more ...

Patient Centricity Where Can Pharma Go From Here

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Offer Details: Dec 10, 2014 · It goes without saying that, without clinical research sites, patients would be cut off from the therapies and the care they need. However, these sites are faced with just as many burdens as sponsors in the realms of drug development, including high operational costs and complex regulations. Given the narrow margins for success, along with the ... See more ...

Email Friend Or Foe Of Effective Communication In Clinical

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Offer Details: Jun 28, 2018 · A director of clinical operations at a global biotech explained: “For some of my team, there is an overwhelming urge to get stuff off their to-do list, as if carrying over an unfinished task to the next day seems like failure to them. See more ...

The False Claims Act Effectively Fights Fraud Waste And

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Offer Details: May 09, 2014 · Recent False Claims Act cases have been filed against companies for grant fraud, fraud in clinical trial billing, fraud on the Food and Drug Administration (“FDA”) ( i.e ., non-compliance with regulations), falsifying and fabricating data in grants or studies, off-label marketing of drugs and devices, and paying kickbacks in post-market ... See more ...

Clinical Leader Live

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Offer Details: Of all the tasks that are handled by executives in clinical operations, few bring as much anxiety and stress as the selection of a CRO partner. Make the right choice and your trial will be a breeze. Make the wrong choice and your trial can go off the rails and require the necessary but hated task of CRO replacement. See more ...

Speed Cost Or Quality In Clinical Trials Don't Pick Two

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Offer Details: Outsourcing practices obviously take some of the day-to-day burden off clinical operations teams, but the responsibility for the trial lies with the sponsor, not the CROs. Recognize the impact of ICH GCP E6 (R2) changes and what it means to implementing QRM in your current efforts in the webinar: See more ...

Central Laboratories Featured Articles Documents on

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Offer Details: Jun 29, 2021 · Coming off the COVID-19 crisis, many of the creative solutions implemented because of the pandemic may actually improve previous work processes and should become part of standard practice going forward. Here are the three new approaches that … See more ...

Phase IV NDA/BLA/MAA - Clinical Leader

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Offer Details: AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources. Therapeutic Expertise: Neuroscience & CNS Datasheet PRA is a leader in the clinical research industry, … See more ...

Articles From Our Expert Network Documents on Clinical Leader

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Offer Details: Mar 02, 2021 · Becoming comfortable with making more abstract contributions rather than providing tangible work and checking off your accomplishments is paramount. A Rose By Any Other Name … What Is A CRA Anyway? 1/5/2021. Ask any project team, or CRA for that matter, what the expectations are for this role and you’ll get vastly different answers. For ... See more ...

6 Tips For An Effective Kick-Off Meeting For A Clinical Trial

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Offer Details: 6 Tips For An Effective Kick-Off Meeting For A Clinical Trial. Kick-off meetings happen routinely at the start of a new clinical trial. Often, they fail to offer participants the information they need or to engage project team members in a way that helps them retain key information. However, with some planning and creativity, a kick-off meeting ... See more ...

Developing A Clinical Trials Strategy For A Post-COVID World

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Offer Details: May 04, 2020 · Experts at the recent town hall shared some strategies for documenting data on missed visits or deviations due to remote, virtual, or off-schedule windows: Capture deviations in a queryable format to be extracted in a report in the future. Write an overarching protocol addendum to capture changes to procedures. See more ...

Was FDA Wrong Annovis Bio Shows Strong Data And No Side

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Offer Details: Aug 17, 2021 ·

Maria Maccecchini, CEO of drug developer company Annovis Bio, has been working on disorders of the brain, including Parkinson’s disease and Alzheimer’s, for more than 12 years. She believes that experience allows her to see the brain a little differently than others. She also believes a treatment Annovis is working on will yield results not … See more ...

Articles by Laurie Halloran

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Offer Details: Jul 23, 2020 · Becoming comfortable with making more abstract contributions rather than providing tangible work and checking off your accomplishments is paramount. Starting A Career In Clinical Research: 7 Things We Wish We Knew 11/24/2020. The clinical research industry is facing a talent shortage that could become acute in the next decade. ... See more ...

Patient Survey Technology Use Up Pharma Disconnect Remains

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Offer Details: Jan 25, 2017 · The report notes the overall frequency of health-based smartphone usage remains low, but investments the industry is making in this area might still be paying off. Fifty percent of respondents reported using smartphone apps or tools to manage their … See more ...

4 Challenges To Overcome In Rare Disease Trials

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Offer Details: Mar 28, 2019 ·

Albireo Pharma is a clinical-stage biopharmaceutical company that was launched in 2008. One of the company’s more promising assets, A4250, is a novel bile acid modulator that has been in development for rare cholestatic liver diseases. The product, which acts locally in the gut, can effectively drain excess bile acids that get stuck in a patient’s liver. In conducting trials ... See more ...

Considerations For The Ethical Use Of Patients In Clinical

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Offer Details: Aug 06, 2015 ·

Linda Strause, PhD, is passionate about the ethical treatment of patients. Her interest in the ethics surrounding human subjects stems out of her work with the San Diego Hospice. She ultimately served as the chair of the San Diego Hospice and Institute of Palliative Medicine IRB for 15 years. While that experience provided her with a close look into the treatment of patients, her interest ... See more ...

Veeva Systems - Clinical Leader

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Offer Details: Veeva Systems Inc. is the leader in cloud-based software for the global life sciences industry. Committed to innovation, product excellence, and customer success, Veeva serves more than 875 customers, ranging from the world's largest pharmaceutical companies to emerging biotechs. See more ...

How Has COVID Impacted The Clinical Trial Pipeline

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Offer Details: Nov 12, 2020 · Although people will not be able to put off healthcare and elective procedures indefinitely, it is difficult to enroll new patients in trials if they are postponing healthcare. Outside the U.S., the environment varies greatly by country and there are opportunities for CROs and sponsor companies to adjust the geographic mix of sites to match. See more ...

Tissue Modeling May Cut Clinical Trial Time

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Offer Details: Dec 05, 2017 · “Our approach involves identifying small molecules which can turn disease genes on or off, depending on the deficit associated with the disease,” says Owen Wallace, chief scientific officer for Fulcrum. “We are looking to either stop or turn on the expression of a particular gene. See more ...

Tackling Health Misinformation Among Hispanics For Better

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Offer Details: Aug 31, 2021 · For example, a recently published studied analyzed the concerns women with rheumatoid arthritis (RA) had about reproduction and breastfeeding while on (or off) biologic medications. An ongoing study is evaluating associations between biometric sensor data, physician-derived data, and electronic patient-reported outcomes (ePROs) over time. See more ...

FDAs Project Orbis Trendsetter Or One-Off

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Offer Details: Nov 06, 2019 · FDA's Project Orbis: Trendsetter Or One-Off. With the announcement of Project Orbis, FDA’s Oncology Center of Excellence (OCE) excited both patients and the pharmaceutical industry with the program’s future possibilities for collaborative regulatory authority interaction in accelerating product approvals worldwide. See more ...

Phase IV IND/CTA/IMD - Clinical Leader

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Offer Details: Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources. See more ...

Veristat - Clinical Leader

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Offer Details: At the onset of the COVID-19 pandemic response, our current client needed help to kick-off a phase I vaccine trial. The sponsor had identified sites and patients and the gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization. See more ...

3 Health Tech Trends Shaping The Future Of Clinical Operations

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Offer Details: Feb 11, 2020 · Well, Walmart isn’t the first or last retail company that will open a nontraditional clinic, and with those new access points, it is crucial that those new care settings partner with a trustworthy carrier to transport the data they generate to its next destination, which could be clinical research trials, research institutions, or off-site ... See more ...

HEALIOS KK Announces Enrollment Of First Patient In Japan

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Offer Details: Apr 23, 2019 · Off-the-shelf stem cell therapy has potential to enhance recovery for ARDS patients. Cleveland, OH (GLOBE NEWSWIRE) - Athersys, Inc. (Nasdaq: ATHX) announced today that its partner, HEALIOS K.K. (“Healios”), has enrolled the first patient in its ONE-BRIDGE study in Japan, evaluating MultiStem® cell therapy treatment of patients who suffer from acute respiratory distress syndrome … See more ...

Monitoring Adverse Event Reporting On Social Media

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Offer Details: Sep 25, 2018 · Set up a monitoring environment to track instances of adverse events being reported. This would involve specialist software tools and detailed filters on social media channels. Each protocol will require different configuration, but, over time, learnings will emerge to speed up new protocol configuration. Once the setup is complete, there is a ... See more ...

“The 12 Months Of Quality” Tips For Building A Voluntary

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Offer Details: Dec 26, 2018 · An off-site location can improve the perception of the experience. It also shows that you value people by taking the session off-site during the workday. 8. August: Creating SOPs takes a village, not an echo chamber. SOP development works much better as a team sport because everyone shares concerns and addresses challenges early on. Quality can ... See more ...

A Proactive Approach To Preparing For The Release Of ICH E6

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Offer Details: Aug 05, 2021 · A Proactive Approach To Preparing For The Release Of ICH E6. Approximately 25 years ago work began on a document intended to revolutionize and improve the efficiency of new drug development. The document, dubbed ICH E6, was intended to provide guidance for clinical trials conducted around the world. ICH E6 is quickly becoming a reality and will ... See more ...

Ciox Life Sciences - Clinical Leader

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Offer Details: Innovation in the area of oncology has taken off at a historic pace. Private industry and the FDA are relying more on big data, specifically multi-source, point-of-care, real-world data (RWD) to power clinical and economic real-world evidence (RWE) outcomes. See more ...

How Can We Begin To Solve Unconscious Systemic Bias In

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Offer Details: Aug 04, 2020 · The author is not assuming this is done on purpose at the site level; however, it may be attributed to lack of time, lack of site resources, lack of knowledge, and/or unconscious bias. Solutions may include: 1. Create and support centers of excellence in rural and urban centers. Sponsors could partner with organizations such as BIO/CTTI/Pharma ... See more ...

Pharma’s Investment In RWE Is Beginning To Pay Off

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Offer Details: Jul 07, 2020 · Pharma's Investment In RWE Is Beginning To Pay Off. For years the life sciences industry has heard about the benefits of investing in real-world evidence (RWE) and real-world data (RWD). According to a recent report from Deloitte, that investment may finally be paying off for companies that climbed onboard and have been building those capabilities. See more ...

Atara Biotherapeutics Announces FDA Clearance To Proceed

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Offer Details: Jan 10, 2018 ·

Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, today announced that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to proceed with patient enrollment at U.S. sites for … See more ...

Five P’s For A Productive CRO Relationship

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Offer Details: Sep 18, 2015 · However, the basic plan for meetings with a CRO would be to have an initial meeting to understand capabilities and services, a second more in-depth meeting with the scientists to discuss your specific project once a Confidentiality Agreement is in place, a kick off meeting once the project is set to begin, and then periodic meetings (weekly or ... See more ...

Strategic Approaches To Risk-Based Monitoring In Clinical

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Offer Details: Oct 03, 2013 · This strategy includes a reduced SDV approach that is aligned to critical data, patient visits or selected patients, depending on the risk-benefit profile of the trial. Triggered monitoring supports an added level of risk management by predefining triggers for planned or additional on-site and off … See more ...

IND/CTA/IMD White Papers & Case Studies Documents on

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Offer Details: Aug 05, 2011 · Assume a generic drug company, let’s call them AB Generics, Inc., always targets the introduction of its generic drugs when the reference product comes off patent. AB’s executive team has looked ahead and seen the generic cliff — few products coming off patent after 2016 — and is looking for alternative revenue sources. See more ...

7 Ways To Modernize Statistical Analytics To Drive

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Offer Details: Aug 10, 2021 · Create A Hand-Off Between Business And IT. IT traditionally builds and maintains computing environments based upon SOPs and other defined processes that ensure reliability, which might be different than the tools or automated processes followed on the business side. As such, there are risk and change management aspects to consider since these ... See more ...

Is A Partnering Model The Best Option For Small Biotechs

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Offer Details: Nov 27, 2017 · When you are ready to outsource, are you better off going with a large or a small CRO? And how big a role should cost, therapeutic expertise, and geographic location play in that decision? Leslie Chong is the CEO of Imugene, a small biotech in Australia working on … See more ...

Cynapsus Therapeutics Announces Positive Phase 3 Dose

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Offer Details: Jul 18, 2016 · About Parkinson’s Disease and OFF Episodes More than 1 million people in the U.S. and an estimated 4 to 6 million people worldwide suffer from PD. It is a chronic, progressive neurodegenerative disease characterized by motor symptoms, including tremor at rest, rigidity and impaired movement, as well as significant non-motor symptoms ... See more ...

Adverse Event Reporting On Social Media — What You Need To

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Offer Details: Jul 17, 2018 · Adverse Event Reporting On Social Media — What You Need To Know. Adverse events (a suspected reaction to the API or to the API in combination with prescribed medicines or environmental factors) are, naturally, a challenging situation for patients in a clinical trial and may, in rare cases, become severe or even fatal. See more ...

2 Key Ways To Improve Patient Recruitment Of Minorities In

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Offer Details: Jun 01, 2021 · For me it’s all about getting great care, not what the caregiver looks like — the problem is when he or she has biases that get in the way of practicing good medicine. Therein lies the problem and that is why so many African American men and men of color in general are turned off by the system. See more ...

Design Thinking in Clinical Trials - May 11 - 12, 2015

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Offer Details: Design Thinking in Clinical Trials May 11 - 12, 2015 - Boston Design Thinking In Clinical Trials (May 11-12, 2015) is the first course taking Stanford's Design Thinking process and applying it to clinical trials to understand how to empathize with the patient. See more ...

How Trial Sites Sponsors Can Deliver On Patient

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Offer Details: Jun 16, 2020 · The time commitment, the potential financial loss from taking time off work, and the costs associated with participating in a research study are all significant factors that play into a patient’s decision to participate. Sponsors and sites can effectively navigate these concerns by realizing that some visits can be conducted virtually and ... See more ...

Four Steps Sponsors Can Take To Increase Patient Recruitment

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Offer Details: Dec 02, 2020 · “Not many patients want to use their paid time off to make numerous visits to a clinic,” says Cajal-Berman. “And yet, we know there is a solution to this problem that clinics can implement. Sites can have late hours one or two days a week or give patients the option of scheduling their visits on a Saturday morning. See more ...

Cambridge Community Forum on CRISPR - December 13, 2017

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Offer Details: Dec 13, 2017 · Cambridge Community Forum on CRISPR December 13, 2017 - Cambridge MA US CBI. [email protected] Phone:800.817.8601 . CRISPR, along with other genome-editing applications, is emerging as a key tool for drug discovery, ranging from target … See more ...

5 Keys To Establishing Quality Partnerships Between

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Offer Details: Mar 13, 2018 · Short-term goals help the team powering through the day-to-day work get a sense of achievement, because some of the milestones in clinical research are a long way off, such as last patient out (LPO). This LPO date could be years after the study team begins setting up the trial. See more ...

Why Astellas And Adaptimmune Are Partnering On STEM-Cell

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Offer Details: Mar 31, 2020 · Adaptimmune is now working with Astellas to make an off-the-shelf platform a reality. In January 2020, the two companies signed an agreement to co-develop and co-commercialize a stem-cell derived off the shelf product, also known as allogeneic CAR-T and TCR T-cell therapies. Some companies working on allogeneic cell therapies have opted to take ... See more ...

A Stem Cell Company Overcomes The Challenges Of

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Offer Details: Aug 26, 2021 · The cells can be used as an ‘off-the-shelf’ stem cell therapy that can be administered like type-O blood. Tissue matching is not required due to the nature of the cells.” Athersys is currently working in collaboration with HEALIOS K.K., a Japan-based company, on the development of MultiStem. See more ...

Cynapsus’ Parkinson’s Disease Therapy Succeeds In Phase 2

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Offer Details: By C. Rajan, contributing writer. Cynapsus Therapeutics has announced positive results from the Phase 2 clinical trial of its lead candidate, APL-130277, for treating OFF motor symptoms of Parkinson’s disease. APL-130277 is a fast-acting formulation of apomorphine, which is designed to help patients quickly gain control of their symptoms. See more ...

FDA Issues Draft Guidance On Electronic Records

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Offer Details: Jul 24, 2017 · The draft guidance provides information to sponsors, IRBs, clinical investigators, and CROs on the use of electronic records and signatures in trials. The guidance, released in June 2017, expands upon recommendations issued in August 2003 by the FDA. In 2003, FDA’s approach was to provide a practical interpretation of Part 11 requirements. See more ...

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