Advanced Clinical

In this webinar, Advanced Clinical will explore best practices for incorporating the perspectives of rare disease patients, caregivers, and HCPs–into clinical trials.

https://www.appliedclinicaltrialsonline.com/act/rare-disease

Rare disease patients and caregivers often face numerous obstacles when participating in clinical trials, and these obstacles are usually the result of a ‘one size fits all’ approach. In recent years, industry professionals are increasingly deploying innovative approaches to both help identify rare disease patients and enable them to actively engage and participate in clinical research. To help gain further insight into the perspective of rare disease patients and investigative sites – as well as enhance their experience participating in clinical research - Advanced Clinical partnered with Know Rare, a company dedicated to connecting patients with clinical research. The partnership conducted a global survey to capture the opinions of rare disease patients, caregivers, and health care professionals (HCP) regarding how to best implement the voice of the patient into rare disease trials.

In this panel discussion, Rebecca Starkie, Senior Global Patient Engagement Director at Advanced Clinical will moderate a panel discussion with industry experts around these survey results, offering insights into effective patient engagement strategies and how new approaches can add value for sponsors, site staff, regulators and - ultimately - patients in need of new treatments
and care regimes.

What are the gaps faced by HCP providers in clinical research and recruitment, and how are HCPs made aware of clinical research studies as a potential treatment option for rare disease patients?

Do patients and caregivers in the rare disease community have an interest in clinical research and do they wish to participate? Do they feel supported?

How can we integrate diversity efforts in rare disease clinical research to ensure the optimal participation pool?

What are some reported obstacles in converting a patient and caregiver from a ‘practice patient’ into a ‘clinical trial patient’?

What are some real-life experiences of patients and caregivers who have participated in clinical research?


Global professionals at pharmaceutical, biotech and medical device and diagnostic companies who are responsible for and/or have an interest in rare disease patient engagement strategies as part of clinical research study design, including:

Site Feasibility, Identification and Selection

Patient recruitment and retention experts


Senior Global Patient Engagement Director
Advanced Clinical

, Senior Global Patient Engagement Director, has spent the entirety of her 24-year career in clinical research, which much of this time focused on strategy and running clinical studies. She has experience in managing studies across a variety of rare disease studies and across all phases. Her most recent experience has been specifically around Patient Engagement, supporting both clients and teams alike with strategies for recruiting and engaging patients. She is passionate about bringing patient engagement to the forefront and has an entrepreneurial mindset liking to think outside of the box. Rebecca holds both a BSc(Hons) Biochemistry and a Certificate in Clinical Research from The University of Leeds, England, U.K



 has experience across many rare therapeutic categories from autoimmune diseases to rare cancers. Her expertise ranges from market research, strategy, to patient and digital marketing. She has experience in developing and leading programs from early-stage clinical trial recruitment and disease positioning through pre-launch and post-launch HCP engagement. Previously Nina founded and led a dedicated patient marketing division for the Interpublic Group.


Neuromuscular Neurologist, Associate Professor of Neurology and Vice-Chair of Clinical Operations, Department of Neurology
Harvard Medical School,Beth Israel Deaconess Medical Center, Boston, MA

 is a neuromuscular neurologist, Associate Professor of Neurology at Harvard Medical School and Vice-Chair of Clinical Operations, Department of Neurology, Beth Israel Deaconess Medical Center, Boston, MA. Upon graduating from Bangalore Medical College, India in 1984, she completed a neurology residency at the National Institute of Mental Health and Neuro Sciences, Bangalore, India in 1991. After moving to the US in 1995, she completed another neurology residency, and a fellowship in Neuromuscular Diseases at the University of Tennessee, Memphis, TN. A fellow of the American Academy of Neurology (AAN), she served as a member of the Guideline Development sub-committee of the AAN for 13 years.




Former Director, Clinical Operations
Arena Pharmaceuticals Inc

 is a clinical operations professional who has worked in the biopharmaceutical industry for more than 14 years. After 10 years of working in Manufacturing and R&D as a chemist, she decided to start a new career in Clinical Operations. Starting as a Clinical Trial Administrator (CTA), Clinical Research Associate (CRA), Trial Manager all the way to a Program Director managing various studies under multiple indications. She has worked both in CRO and biotech companies gaining experience in therapeutic areas such as cancer, hepatic rare diseases, and cardiovascular indications to name a few. She has helped build infrastructure and processes related to SOPs,TMF, vendor oversight and site management. 


Webcasts

Webinar Date/Time: Thu, Mar 9, 2023 11:00 AM EST


How to Make Your Rare Disease Trials More Patient and Site-Centric

http://www.appliedclinicaltrialsonline.com/act_w/patient_narratives

Safety departments often take a one-size-fits-all approach to writing clinical narratives—and that could be introducing unnecessary risks to how individual cases--and later studies--are interpreted.

While it may seem prudent to include every single detail of a patient’s medical history in a case narrative, an overabundance of information buries the salient points. It makes it difficult for regulators to assess the cause of the safety issue and runs the risk that irrelevant data will get pulled into the adverse event determinant. However, when authors take the time to combine a patient’s relevant medical history with safety event details and focus on potential causes of the event, it is easy for regulators to understand what happened and what was the likely cause.

In this webinar, Advanced Clinical experts, Claire Brazier, Director of Global Patient Safety, and Anna Fudim, Medical Director, will discuss how to write a custom patient narrative and why this approach adds value for sponsors, site staff, patients and regulators.

The most important rules for writing custom patient narratives

The roles and responsibilities of investigators and case processors in narrative writing

How to verify whether your narrative is correct, logical and fluent

Best practices from real-world examples of custom patient narratives


Director of Global Patient Safety
Advanced Clinical

Wed, Oct 19, 2022 11:00 AM EDT

In this webinar, Advanced Clinical will explore best practices for writing custom patient narratives and how this approach adds value for sponsors, site staff, patients and regulators.




Are Your Patient Narratives Too Broad? 

http://www.appliedclinicaltrialsonline.com/act_w/protocol


Many clinical teams rely on outdated or limited strategies for feasibility and assume this is a ‘one and done’ activity that can be completed quickly within the RFP process. In today’s clinical research environment, feasibility requires a robust multi-channel strategy and a risk management feedback loop to monitor and mitigate risks throughout the project.

Advanced Clinical experts—Dan Sabou, MD, Country Manager and Medical Director and Donna Hanson, Senior Director, Strategy and Optimization—will explore the fundamentals of feasibility, the necessity to broaden approaches, how to leverage technologies, and processes, as well as discuss how all of this combined can deliver more actionable insights from feasibility assessments. Learn through real-world examples and experience of the Advanced Clinical team how organizations can work with their partners to optimize feasibility assessments, mitigate risks and improve results.

Feasibility approaches and why multi-channel methodologies deliver optimized results

How to conduct an effective feasibility assessment to set the course for a successful study

Technologies and processes that can optimize your feasibility strategy to deliver better and more actionable insights

The future of feasibility and how to adapt your current methods to embrace what lies ahead

The benefits that optimized feasibility can bring to a study


Global professionals at pharmaceutical, biotech, and medical device and diagnostic companies who are responsible for Study Feasibility decisions, including:


Senior Director, Strategy and Optimization
Advanced Clinical


Donna Hanson, Senior Director, Strategy and Optimization with Advanced Clinical, has been in the clinical trial industry for nearly 20 years. Donna has a comprehensive background including leading teams in patient recruitment and engagement, feasibility and site engagement, bids and proposals and vendor management/outsourcing. Her passion is to enhance strategy and study optimization to expeditiously complete trials that provide access to cutting edge treatments to those in need, faster. Donna’s experience spans multiple therapeutic areas, with a large focus in urology, gastroenterology, rare disease, oncology and pediatric programs.


Country Manager and Medical Director
Advanced Clinical

Dan Sabou, MD, Country Manager and Medical Director, has worked in clinical research for over 12 years and is a board-certified physician, including university teaching experience. As a member of the Global Medical Services department, Dan provides medical and surgical advice to clients and within Advanced Clinical. This includes consulting on clinical development plans, protocols, KOL development, site networks, and medical/safety monitoring (medical monitoring and safety management plans, medical monitoring and medical case review). He holds a Doctor of Medicine degree from Victor Babeș University of Medicine and Pharmacy in Timisoara, Romania.

Now Available On Demand!

In this webinar, we will explore best practices to optimize your protocol, country and site feasibility strategy by employing a robust multi-channel strategy and a risk management feedback loop to monitor and mitigate risks throughout the project.

Best Practices for Optimizing Your Protocol, Country and Site Feasibility Strategy

 http://www.appliedclinicaltrialsonline.com/act_w/market

The clinical research industry continues to become highly competitive, as drug development funding increases and as the effects of the global pandemic have accelerated the need for new treatments and new ways of working. In order to manage the most effective clinical trials, Sponsors must be equipped to address resourcing requirements and have the flexibility to support their teams of researchers with the most qualified professionals. Companies who manage clinical research operations must incorporate recruiting strategies or risk losing good candidates to their more agile competitors in a demanding market.

In this webinar, experts Kimberley Ball and Adrea Widule will discuss proven recruiting techniques that pharmaceutical and biotechnology companies can apply today to attract more candidates and convince them to accept offers quickly – while creating an engaging employee experience for talent.

How to create a compelling digital presence that showcases your culture and brand at every touchpoint

What the most experienced and qualified clinical research candidates are seeking in terms of benefits, career development, corporate culture, diversity and inclusion -- and how to communicate that throughout the recruiting process

How hiring managers can streamline recruiting so they don’t lose high quality candidates

Ways to build lasting relationships with ‘short list’ candidates for more efficient, future-forward recruiting strategies

Global leaders at pharmaceutical, biotech, and medical device and diagnostic companies who are responsible for resourcing and outsourcing decisions in the following functional areas:

Quality Infrastructure and Auditing Services


Director, Business Development
Advanced Clinical

Adrea Widule is a Director of Business Development for Advanced Clinical. She has more than seven years of staffing experience with the organization. Originally from northern Wisconsin, Adrea graduated from the University Wisconsin Milwaukee with a Master’s degree in Cultural Foundations of Education before obtaining an MBA in International Business from The University of Scranton. She is excited about the clinical research industry’s digital transformation and its potential to dramatically improve new therapeutic options and patient care.


Senior Clinical Recruiter
Advanced Clinical


Kimberley Ball is a Senior Clinical Recruiter with Advanced Clinical. Kimberley holds a degree in Marketing from Southern Illinois University-Carbondale and is originally from central Illinois. Prior to joining Advanced Clinical in February 2014, she worked in market research for the financial industry, with a focus on e-commerce initiatives. Kimberley is passionate about supporting clinical research and trials and finds the relationships she builds with those positively affected by live-changing developments to be particularly rewarding.

http://www.appliedclinicaltrialsonline.com/act_w/marke

Thursday, September 16, 2021 at 11am EDT | 8am PDT | 4pm BST | 5pm CEST
In today’s highly competitive clinical research landscape, Sponsors must be equipped to ramp up resourcing needs at a moment’s notice. This webinar will discuss proven recruiting techniques that pharmaceutical and biotechnology companies can apply today to attract more candidates and convince them to accept offers quickly – while creating an engaging employee experience for talent.

How to Attract Clinical Research Talent in a Highly Competitive Market: Best Practices for Resourcing Your Team

http://www.appliedclinicaltrialsonline.com/act_w/clinical_oversight

Clinical oversight contributes to the success of global trials by ensuring the protection of trial participants as well as the integrity of the data collected. Global regulators are increasingly seeking more formal documentation of sponsor oversight activities during inspections.

Sponsors who are not involved in their clinical oversight processes, or who follow informal documentation strategies, run the risk of inspection findings (e.g., FDA-483) that can cause delays, fines, and potentially impact regulatory approvals. When sponsors choose to outsource this critical function, the pros and cons must be carefully considered.

Learn about the background of clinical oversight, including current global regulations, implications of COVID-19, decentralized trials, and more

Understand the importance of the sponsor/CRO relationship when executing oversight activities, including the difference between quality vs monitoring vs oversight

Learn best practices for sponsors who are planning c linical oversight activities but may be unsure whether keeping this function in-house is more efficient than outsourcing

Explore how sponsors can leverage alternative delivery models to help mitigate risks and streamline processes

Nan Croy, Director of Functional Service Solutions, Advanced Clinical

Vice President, Clinical Operations Quality & Talent Development, Advanced Clinical

at 11am EDT| 8am PDT | 4pm BST | 5pm CEST

On demand available after final airing until Apr. 13, 2022

*** Tuesday, April 13, 2021 at 11am EDT| 8am PDT | 4pm BST | 5pm CEST *** In this webcast, we will explore best practices for building an effective Clinical Oversight function using a variety of different delivery models. *** On demand available after final airing until Apr. 13, 2022 ***

Best Practices for Building a Successful Clinical Oversight Function

http://www.appliedclinicaltrialsonline.com/act_w/accelerate

 COVID-19 required the life sciences industry to rapidly embrace decentralized clinical trials (DCTs) to keep clinical research moving forward during the pandemic. This virtual approach helped the industry maintain continuity in research while meeting the needs of patients in their homes.

The forced transition caused many sponsors to realize the benefits of a decentralized model, which include reducing the burden on patients, expanding the reach of trial sites, and leveraging technology to more rapidly collect, analyze and respond to clinical data.

It’s time to look beyond the current moment and understand how this will impact the future of clinical research. We must rethink strategies for clinical trial models to accommodate the new skills, jobs, and technology demands required in a virtual environment.

In this webcast we will explore the changing roles played by sponsors, CROs, site staff, and other stakeholders in DCTs - and how to ensure patients still get the support they need in these virtual research environments.

Explore how DCTs are changing roles, and where you can merge roles to gain efficiencies

Understand the new skills and talent that site staff will need to succeed in a DCT environment

Discuss the additional vendor and community relationships required to meet patient needs

Discuss how sites can create intentional moments of engagement with remote patients to ensure their needs are being met

 Tracy Parker, Vice President, Biometrics, Advanced Clinical

Karen Grossberg, Vice President, Clinical Operations, North America Advanced Clinical

 Thursday, December 10, 2020 at 11am EST 

***Live: Thursday, December 10, 2020 at 11am EST | 8am PST | 4pm GMT | 5pm CET ***In this webcast, we will explore the changing roles played by sponsors, CROs, site staff, and other stakeholders in decentralized clinical trials (DCTs) - and how to ensure patients still get the support they need in these virtual research environments. ***On demand available after final airing until Dec. 10, 2021***