24 May
Resources

Infectious Disease CRO Services: Access ClinFocus Experience

ClinFocus is an award-winning contract research organization (CRO) that is able to support sponsors with client-focused infectious disease CRO services. Why choose ClinFocus for your infectious disease clinical trial? For more information on our experience and capabilities, download our Infectious Disease Experience Overview below.

Infectious Disease CRO Services

The ClinFocus Research team has clinical research expertise in a wide range of therapeutic areas, including extensive infectious disease experience.  We offer pharmaceutical and biotechnology companies of all sizes clinical operations, project management, biostatistics, data management, and strategic clinical trial consulting services.

ClinFocus Research is an award-winning CRO that has supported over 900 clinical trials since 2007. With a 95% client retention rate, we offer client-focused support with an attentive, experienced team. ClinFocus is privately owned with two United States offices based in North Carolina (Durham, NC in the Research Triangle Park (RTP); Wilmington, NC).

In addition to extensive infectious disease experience, ClinFocus is able to provide clients with industry-best biometric timelines. In fact, our team is able to provide sponsors results, on average, one month faster than the industry standard.

For more information about our team, our capabilities, and how we can support your infectious disease clinical trial, download the infographic above or get in touch with one of our representatives. We’re looking forward to supporting you!

 

Additional Relevant Resources

ClinFocus Research has the right experience and capabilities to provide excellent support and services to sponsors of all sizes. Browse some of our resources below.

24 May
Resources

Oncology CRO Services: Access ClinFocus’s Experience

ClinFocus is an award-winning contract research organization (CRO) that is able to support sponsors with client-focused oncology CRO services. Why choose ClinFocus for your oncology clinical trial? For more information on our experience and capabilities, download our Oncology Experience Overview below.

Oncology CRO Services

The ClinFocus Research team has clinical research expertise in a wide range of therapeutic areas, including extensive oncology experience.  We offer pharmaceutical and biotechnology companies of all sizes clinical operations, project management, biostatistics, data management, and strategic clinical trial consulting services.Within oncology, our experience includes both blood cancers and solid tumors.

The PharPoint team also has experience within immunotherapies and immuno-oncology, and understands the nuances of managing and monitoring a study within I-O.

 

About ClinFocus

ClinFocus Research is an award-winning CRO that has supported over 900 clinical trials since 2007. With a 95% client retention rate, we offer client-focused support with an attentive, experienced team. ClinFocus is privately owned with two United States offices based in North Carolina (Durham, NC in the RTP; Wilmington, NC).

In addition to extensive oncology experience, ClinFocus is able to provide clients with industry-best biometric timelines. In fact, our team is able to provide sponsors results, on average, one month faster than the industry standard.

For more information about our team, our capabilities, and how we can support your oncology clinical trial, download the infographic above or get in touch with one of our representatives. We’re looking forward to supporting you!

 

Additional Relevant Resources

ClinFocus Research has the right experience and capabilities to provide oncology CRO services to sponsors of all sizes. Browse some of our resources below.

24 May
Resources

Cardiovascular CRO Services: Access ClinFocus’s Experience

ClinFocus is an award-winning contract research organization (CRO) that is able to support sponsors with client-focused cardiovascular CRO services. Why choose ClinFocus for your cardiovascular clinical trial?

For more information on our experience and capabilities, download our Cardiovascular Experience Overview below.

Cardiovascular CRO Services

cardiovascular cro services image

The ClinFocus Research team has extensive clinical research experience in a wide range of therapeutic areas, including cardiology.  We offer pharmaceutical and biotechnology companies of all sizes clinical operations, project management, biostatistics, data management, and strategic clinical trial consulting services.

ClinFocus Research is an award-winning CRO that has supported over 900 clinical trials since 2007. With a 95% client retention rate, we offer client-focused support with an attentive, experienced team. ClinFocus is privately owned with two United States offices based in North Carolina (Durham, NC in the RTP; Wilmington, NC).

In addition to extensive cardiovascular experience, ClinFocus adheres to industry-best biometric timelines. In fact, our team is able to provide sponsors results, on average, one month faster than the industry standard.

For more information about our team, our capabilities, and how we can support your cardiovascular clinical trial, download the infographic above or get in touch with one of our representatives. We’re looking forward to supporting you!

 

Additional Relevant Resources

ClinFocus Research has the right experience and capabilities to provide cardiovascular CRO services to sponsors of all sizes. Browse some of our resources below.

24 May
Resources

ClinFocus Research to Attend World Vaccine Congress Washington 2021

ClinFocus Research will be in virtual attendance at the event, which is being held from May 4th to May 6th.

 

About the World Vaccine Congress

The conference, organized by Terrapinn, is the “largest, most established meeting dedicated to vaccines.” Attendance at the event is free. To sign up, visit the Terrapinn website.

This year, the event is expected to cover:

  • COVID-19
  • Immune Profiling
  • Cancer Immunotherapy
  • Respiratory & Infectious Disease
  • Vaccine Safety
  • Clinical Dvelopment
  • Market Access
  • Vaccine Supply & Logistics
  • Bioprocessing & Manufacturing
  • Biodefence
  • Anit-Microbial Resistance
  • One Health

 

Keynote speakers attending the event include the WHO’s Director of Vaccines Dr. Kate O’Brien, the COO of COVAXX Christina Yi, and the CMO of Moderna Dr. Tal Zaks, among many others. ClinFocus’s team is thrilled to be in attendance, and looking forward to hearing from and speaking with attendees.

About ClinFocus Research

As an award-winning CRO, the ClinFocus Research team has extensive experience within infectious disease, including 5 regulatory submissions and over 300+ studies supported by our biometric team since 2007. ClinFocus provides clinical operations, project management, biostatistics, statistical programming, data management, and strategic clinical trial consulting services to clients of all sizes with a 95% client retention rate.

Attending the event and interested in speaking with a member of our team to learn more about how ClinFocus’s industry-best standard timelines and infectious disease expertise can support your upcoming study?

Fill out the form below and a representative will be in touch to schedule a time to speak with you.

Are you at a biotech or pharmaceutical company that will be attending this years World Vaccine Congress Washington 2021?

Reserve a spot on our team’s calendars with the form below. We’re looking forward to speaking with you!

24 May
Resources

Celebrating Clinical Trials Day 2021: The Evolution of Clinical Research

Every year on May 20th, the industry celebrates International Clinical Trials Day, acknowledging patients and their families, nurses and physicians, researchers, and the many others who participate in clinical research to make advances in treatments possible.

 

The History of Clinical Research

The First Recorded Controlled Trial: Dr. James Lind

James Lind, a Scottish physician born in 1716, is considered the very first physician to have performed a controlled clinical trial in the modern era.

Lind, while working as a surgeon on a ship in the British Royal Navy, noticed the high mortality rate of scurvy among sailors. In an attempt to find a more effective method for treating the disease, Lind designed a comparative trial. The trial included various treatment plans for 12 different sailors affected by scurvy.

In his in-depth recordings of the trial, he explained, “Their cases were as similar as I could have them… they lay together in one place… and had one diet common to them all.”

After his trial, Lind noted that the “most sudden and visible good effects” were seen in patients who consumed oranges and lemons in addition to their common diets.

The Introduction of Placebo

While Lind’s study may have paved the way for controlled trials, it took nearly 150 more years for the placebo to be introduced.

In 1863, US physician Austin Flint planned a clinical study that compared a “dummy” treatment to an active one. His study, which included 13 patients with rheumatism, gave subjects an herbal extract as opposed to the established remedy for rheumatism.

Flint would later describe the treatment as a “placeboic remedy.”

Clinical trials of the 1940s: Introducing Randomization and the Double-Blind approach

In the early-to-mid 1940s, modern approaches to clinical research came to fruition.

In 1943, a British group carried out the first double blind controlled trial while investigating a treatment for the common cold. (Unfortunately, the analysis of trial data did not show any protective effect.)

Three years later in 1946, the first randomized controlled trial took place. The study, conducted in the UK, used a meticulous design and implementation plan to analyze the effect of streptomycin in pulmonary tuberculosis.

 

The Introduction and Evolution of Contract Research Organizations

The first CRO-like companies were established in the 1940s and 1950s. These companies typically provided animals for clients to run tests on or conducted animal testing themselves. They weren’t just limited to pharmaceuticals – the “original CROs” worked with clients in a range of scientific areas.

As regulation increased for pharmaceutical products in the 1960s, however, offering preclinical testing of toxicology services for pharmaceutical companies became popular.

In the late 1970s and 1980s, new players were introduced, and the industry as it is today began to emerge. Companies like Quintiles (now IQVIA), Parexel, and PPD began. In addition to the traditional preclinical testing role, companies began offering services such as clinical trials, logistics, statistics, data management, and other functions.

 

The Rapid Growth and Expansion of CROs

By the late 80s and 90s, the industry was very rapidly developing.

In the 1980s, blockbuster drugs such as the first statin and the SSRI Prozac were approved – and costs in the industry were quickly rising.

Between the 1990s and the mid 2000s, CRO services increased from 4% of R&D spend to nearly 50%. A flood of mergers and acquisitions began. Some CROs began offering outsourcing for areas like drug discovery and medical marketing.

The relationships between CROs and pharmaceutical companies also began changing.

“If a drug company wanted,” an article by Robin Walsh on pharmaphorum describes, “it could do no work of its own at all, outsourcing the entire process to CROs.”

 

The CRO Industry Today & Beyond

As of 2021, reports have stated that the global CRO industry is expected to reach over $64 billion by 2027. It also continues to be marked by a number of mergers and acquisitions (such as ICON plc’s $12 billion acquisition of PRA Health Sciences in late February 2021).

The COVID-19 pandemic has certainly had an effect on the CRO industry. For one, it has accelerated the adoption of trial decentralization. According to an Oracle study, 76% of survey respondents had stated that the pandemic had accelerated their adoption of decentralized clinical trials (DCT).

24 May
Resources

CRO Red Flags: Signs Your Study is Being Put at Risk & Considerations for Selecting a Rescue Partner

Failed enrollment – especially when combined with obstacles like poor quality, poor communication, severe bottlenecks, or lost access to resources – sometimes necessitate a rescue to “save” a trial from an underperforming CRO.

Study rescues are a delicate and complex process.

When possible, we advise bringing in a clinical trial consultant as soon as you develop study concerns. An unbiased third party can accurately advise you on what kind of rescue you may need and walk with you through the rescue process.

 

Each scenario is different, and an experienced consultant focused on the “big picture” can help determine the most cost-effective—and least stress-inducing—fix. Options for study rescues may include:

  • Can your study get back on track with simple oversight?
  • Should a companion CRO take on part of your current CROs workload?
  • Do you need a full study takeover?

 

 Seven Signs Your CRO is Putting your Study at Risk

  1. You’ve experienced a team bait-and-switch: You were initially impressed by the expert team you met at a bid defense meeting…but once your study started, you were assigned a totally new, less experienced group to work with.
  2. You’re frustrated by a lack of timely communication: The team members you’re supposed to be working with aren’t responding to your emails or returning calls in a timely manner.
  3. Your CRO can’t explain how they’re going to achieve their aggressive timelines: It’s a red flag when you’re being presented with crazy-impressive timelines that have no information or experience to back them up. Over-optimism partnered with under-planning is never a good sign.
  4. You notice a lack of coordination across vendors: There are many people involved in the clinical research process, and these parties need to be able to work cohesively under the guidance of your CRO.
  5. You haven’t signed off on start-up documents yet, and you’re getting worried: Your CRO didn’t create a plan for communication at kickoff. Along the same line, you should have received—and signed off on—important documents like study start up plans such as the clinical monitoring plan in a timely manner, as well.
  6. Your CRO doesn’t seem to be using any of the right tools or technology: For example, your CRO is collecting data in Excel spreadsheets instead of a system designed to handle clinical trial data.
  7. Your CRO is not cleaning data in a timely manner: Your data doesn’t seem like a priority for your CRO.
24 May
Resources

Site Feasibility: Increasing Speed to First Patient in and Maximizing Enrollment Potential

With thorough site feasibility processes, sponsors can increase speed to first patient in and maximize enrollment potential.

According to Pharma Intelligence Informa, two-thirds of all clinical trial sites are unable to meet enrollment goals. Half of all sites recruit one or zero patients. 

Even for trials that are able to meet recruitment goals, 86% experience delays, with actual enrollment timelines typically 2x their planned estimates (averaging 8 months to initiate a trial from site identification to first patient in). 

These are daunting numbers. What can a sponsor do to minimize the risk of delays, enrollment failures, and sunk costs? 

Selecting the Right Sites: Best Site Feasibility Practices 

A well-planned study with properly selected sites can decrease costs and speed up the study timeline.  

Poor enrollment can lead to the need to seek out and bring in new investigators, drawing out timelines. It may also require an adjustment to eligibility criteria, and protocol amendments may move a study several steps back.  

At the very least, underperforming sites add extra opportunity costs. 

At the worst, a study’s target enrollment may never be reached, and your entire program may be compromised. 

During the site selection process, sponsors/CROs should consider the following (uncomprehensive) list: 

  • Assessing general site feasibility questions 
    • Are there any regulatory red flags?
    • Does the site have the right resources (equipment, staff, etc.) to allow the trial to be successful? 
  • Assessing epidemiology and patient population 
    • Is the site located in an area with a high incidence of the disease of interest? 
    • Does the site have access to the targeted patient population? 
  • Assessing historical performance site-by-site 
    • Does the site have successful experience within clinical research? 
    • Does the site have efficient regulatory, contract, and budgetary processes? 
    • Does the site have successful experience within the study’s therapeutic area? 
    • Does the site have a history of meeting enrollment goals?
  • Assessing experience of investigators and site staff 
    • Does the PI/site staff have experience within the study’s therapeutic area/indication? 
    • Does site staff have the bandwidth to take on more studies? 
    • Does the investigator have a vested interest in the condition? Is it an area of focus for their practice, or are they recognized as an expert? 
24 May
Resources

4 Key Considerations for Managing and Monitoring Neurology Clinical Trials

Neurology clinical trials are highly complex. ClinFocus’s team uses the following key considerations, along with extensive industry expertise, to successfully manage and monitor neurology trials for our clients.

1) Understanding of neurological pathologies and neurological assessments

More than just therapeutic experience, partnering with a team that has a whole picture understanding of neurological conditions, clinical assessments, IP administration and how they all relate can help add valuable insight to a study. This requires an understanding of the subject’s potential reactions to clinical assessments and their relation to adverse events.

For example:

  • Does the study condition present with hypersensitivity (such as MS or Lupus)? How may this impact reactions to IP administered through injection?
  • How may patients with cognitive disorders react to imaging – like being placed in an MRI?
  • Does your study require blinded or unblinded raters for subjective assessments?

 

2) Ability to ensure the right resources & expertise to facilitate the flow of study information

Neurology studies, like many others, are often highly complex and may have vast amounts of study information and study partners involved. Is your neurology CRO able to properly facilitate this flow of information?

At ClinFocus, we target appropriate vendors and high performing sites, and we ensure an adequate amount of time is committed to set up. We use repeated testing to ensure everything works as it should. We also assign study team members who can dedicate time just to ensuring the flow of information is uninterrupted, with the ability to react to a changing environment, if needed.

 

3) Selecting and managing qualified, experienced vendors

The proper vetting, onboarding, and management of any additional teammates a study may need is critical. Through the use of a best-in-class model,  sponsors can ensure that the right vendors – the most qualified, cost-efficient, and experienced – are selected for the job. These teammates are typically specialized experts in what they do, and help define clinical endpoints in neurological studies.

 

4) Considerations of a mindful collection of patient reported outcomes (PROs)

Pain, quality of life, and impact on daily activities are all patient reported outcomes that are nearly universal to neurology studies.

Neurological conditions impact how you perceive and experience sensations such as pain, sense of small, vision, etc. With such a reliance on PROs, it’s important to thoughtfully consider the best way to collect data. Consider the patient population: are electronic or paper PROs going to be the best approach for your specific study?

24 May
Resources

CRO Selection Checklist: 27 Things to Know

Here are 27 things that your CRO selection checklist should include.

 

The CRO selection process often seems daunting.

Clinical trials are lengthy and expensive, and you don’t want to feel “stuck” with a CRO who’s a poor match for your study needs, who struggles with quality, or who can’t stick within anticipated timelines & expected budgets.

The right CRO for you is one that is a best match for your individual study needs. While there is no one-size fits all approach, the below items provide a helpful guide to begin.

 

The right services and expertise for your study needs

  1. Do the CROs capabilities cover your specific trial needs?
  2. Does the CRO have experience in your study phase?
  3. Does the CRO offer an option for decentralized study capabilities and proactive solutions to decentralized clinical trial obstacles?
  4. How does the CRO work with a proactive approach that keeps your submission in mind from the start?
  5. Can the CRO create and provide custom SAS programming?

NOTE: During the submission process, the FDA requests programs for ADaM datasets as well as the programs for the efficacy output. When sponsors use proprietary compiled macros rather than custom programming, additional steps must be taken before review by the FDA or other regulatory agencies.

 

The right team (without any bait & switch techniques)

  1. Are the study team members highly qualified and experienced within your therapeutic area or indication?
  2. Does the CRO provide clear communication on how they plan to stay within scope or expand scope only with explicit approval?
  3. Does the CRO practice transparent pricing, including a detailed explanation of service costs and thorough definition of pass-through costs?
  4. Does the CRO have an experienced business development staff with excellent and effective communication?
  5. Does the CRO offer clear escalation paths, including access to director and/or executive level personnel, if needed?
24 May
Resources

3 Reasons Why You Should Work in the Clinical Research Industry

Considering a career in clinical research? Working at a Contract Research Organization (CRO) like ClinFocus Research, based in North Carolina with employees across the US, may be a perfect fit for you.

A CRO is a service-based company that supports other innovative companies as they pursue market approval for new drugs, biologics, and/or medical devices.

The CRO industry is sizable and continues to grow. Globally, the clinical trials market size was estimated at $44.3 billion in 2021. It’s expected to continue expanding at a compound annual growth rate of 5.7% from 2021 to 2028, according to data from Grandview Research.

This growth is primarily driven by increased investment in biotechnology and pharmaceutical companies. Most pharmaceutical and biotechnology companies outsource certain services during the clinical trial process to improve profitability, meet rapid timelines, and save costs. They may rely on a CRO for services such as clinical operations and project management, data management, biostatistics, statistical programming, and medical writing.

What makes working at a CRO a fulfilling career?

1. The chance to support efforts to improve global health

According to IPSOS’s Global Happiness 2020 Report, 80% of respondents feel that having meaningful work or employment gives them happiness.

Working within the clinical research industry means you’re contributing to improvements in global health. As an employee at a CRO, you get the chance to work behind the scenes as investigative products go through the clinical trial process. While not all products make it to market approval, having a small role in the few that do – and that are able to change the lives of patients around the globe – is no small matter!

2. Professional growth and development

As the industry continues to grow, the need for talented employees grows along with it. Highly skilled professionals are needed to keep pace with an evolving industry. CROs recognize this, and the best ones will have training programs and/or mentorship-focused cultures to help develop future talent.

At the right company, opportunities for growth will be ample.

One way PharPoint supports employee growth is through our Training and Development program. PharPoint’s program includes both instructor-led courses on a range of topics along with an extensive library of self-paced virtual courses!

3. Challenging work and variety

According to a 2018 report by Korn Ferry that surveyed 4,900 professionals, 1 in 3 employees planning on looking for a new job were doing so because they were bored at their current job and needed a “new challenge.”

By working at a CRO, where an employee may be playing a role in a variety of different studies across a variety of different therapeutic areas and indications, there is constantly something new to learn or dive deeper into.

CRO staff may work to achieve high production, think of solutions to overcome obstacles, and – especially when working at a mid-sized CRO like PharPoint – find room for innovation. (Looking for examples? Check out a few of our case studies!)

 

Getting Started in the CRO Industry

How can you get started in the CRO industry?

PharPoint Research is always seeking talented candidates to join our team. We believe in investing in the future of the industry. PharPoint has a history of developing and mentoring interns as they grow into industry experts.