How PharPoint and Medrio Achieve Phase I Success

Electronic Data CaptureAt PharPoint Research, we set ourselves apart from the competition by consistently meeting tight deadlines for our customers. Several years ago, we faced the challenge of finding an affordable, high-caliber electronic data capture (EDC) solution for our early phase research. After reviewing many systems, PharPoint chose Medrio as their EDC provider for Phase I studies. Nearly five years and numerous studies later, we continue to use Medrio because of their rapid study start up and responsive customer service. Click below to read more about how Pharpoint utilizes Medrio to support its rapid Phase I operations.

PharPoint’s Phase I Success

It is widely recognized within the pharmaceutical and medical device industries that there is a distinct competitive advantage that comes with being first to market. Every month of lead time ahead of a competitor is meaningful, as first-movers usually acquire significantly greater market share in the long run. As such, clinical research sponsors seek to expedite the clinical trial process as much as possible, and they look for contract research organizations (CROs) that can complete studies rapidly while maintaining accuracy.

At PharPoint, a North Carolina based CRO, we set ourself apart from the competition by consistently meeting tight deadlines for its customers. Handling studies across all phases and therapeutic areas, PharPoint utilizes Medrio to support our rapid Phase I operations. Medrio’s simple, fast, and affordable electronic data capture (EDC) software meets strict regulatory standards and fits within limited Phase I budgets.

Working with Medrio

Several years ago, PharPoint faced the challenge of finding an affordable, high-caliber EDC solution for their early phase research. Custom-developed software and on premise data hosting were simply not an option. After reviewing many systems, PharPoint chose Medrio as their EDC provider for Phase I studies. Nearly five years and numerous studies later, PharPoint Research continues to use Medrio because of its rapid study start up and responsive customer service. “PharPoint consistently works with Medrio across Phase I studies because of their flexibility and talent for meeting deadlines on short notice,” says Moya Hawkins, Director of Data Management.

PharPoint consistently works with Medrio across Phase I studies because of their flexibility and talent for meeting deadlines on short notice.
− Moya Hawkins, Director of Data Management

Intuitive Design, Outstanding Support

Cumbersome EDC software often results in slow and inaccurate data collection, which is why it comes as no surprise that most CROs rank intuitive design as a top concern when searching for the right EDC solution. Listening to the customer’s needs, Medrio has developed an easy to use EDC platform that does not require extensive training or technical expertise. Moya sees the difference: “Medrio’s detailed training program reduces the learning curve and ultimately saves time when onboarding new team members and site users. As a partner with Medrio, we also value the ability to design entry screens and custom edit checks to sponsor specifications.”

Medrio’s fluid learning transition is built on a deep understanding of our customers’ needs. They understand that many of their clients work beyond the typical 9 – 5, which is why their highly responsive customer success team, located at our headquarters in San Francisco, is available to help customers any day of the week. They have invested a great deal of company resources into their customer support infrastructure because they believe customer needs come first. Moya appreciates Medrio’s customer focus: “Medrio’s dedication to customer support allows us to finalize a contract and get a study partitioned in less than 24 hours. No other EDC company has been able to deliver the same turnaround time without loss of quality.”

Medrio’s dedication to customer support allows us to finalize a contract and get a study partitioned in less than 24 hours. No other EDC company has been able to deliver the same turnaround time without loss of quality.
− Moya Hawkins, Director of Data Management

About Medrio

Founded in 2005, Medrio offers an integrated eClinical software platform with a fully hosted Electronic Data Capture (EDC) system. Their revolutionary SaaS technology drastically reduces study timelines and costs by giving study managers more control over their studies. By simplifying and streamlining the data collection process – without the need for any custom development – Medrio allows researchers to build their studies in days instead of months without any programming knowledge. Plus, Medrio costs up to 75% less than traditional EDC solutions. Their diverse set of customers includes CROs and sponsors conducting studies across all study phases and therapeutic areas and ranges from newly formed startups to the top 5 biopharmaceutical companies.

Attachments: How Medrio and Pharpoint Achieve Phase I Success

Organ-On-A-Chip to Eliminate Animal Testing

Animal TestingAnimal testing is necessary for the safety of drug development, but success in animal testing does not always indicate success in human trials. An animal’s reaction to a drug can drastically vary from that of a human’s which can lead to unforeseen adverse effects and inaccurate findings. In addition to health threats, there are financial risks associated with misleading results in an animal study. Clinical trials are expensive and a lot of money could potentially be wasted if a drug shows promise in animal trials but turns out to be ineffective in humans. Time, money, and even lives can be saved if there were a more accurate method of testing new drugs.

The Solution?

The organ on a chip is a microchip lined with human cells that exactly replicates the function and environment of full sized organs in the body. Take for example the lung on a chip. Inside the lung on a chip are two hollow channels separated by a porous membrane with one side coated in lung cells and the other in pulmonary cells. This structure creates two chambers, one allowing for air flow and the other for blood flow, mimicking the function and composition of the air sacs in a real human lung.

Organs on chips could be beneficial in many applications of the drug development world. Researchers could test a drug’s impact on a certain part of the body and closely observe the pharmacokinetics and their impact on each system. This would help scientists better predict side effects and whether or not a certain drug is safe. When all of the organs on chips are put together, researchers will be able to discover exactly how the human body will react to the drug being administered. The implementation of organs on chips would provide more dependable results than that of animal testing. This is because trials on animals oftentimes produce outcomes that do not accurately reflect what would occur in humans. For example, an animal’s body may metabolize drugs quicker or be more tolerant of a certain compound which are important factors to consider when developing a drug.

Conclusion

However promising it may seem, the organ on a chip has a ways to go before it eliminates animal testing. Insight into neurological side effects is gained from animal testing which is information that could not otherwise be observed. Additionally, Organs on chips and animal testing could be used complementary to create a more complete picture as scientists work to develop more alternatives. Regardless, a step towards eliminating animal testing is a monumental achievement and the organs on chips will certainly revolutionize early stage drug development like never before.

Attachments: Organ-On-A-Chip to Eliminate Animal Testing

Stasis Foam Set for the Battlefield

DARPA’s Stasis Foam Set for the Battlefield

Stasis Foam

In modern medicine the term “Golden Hour” refers to the first sixty minutes following a traumatic injury. During this hour, there is the highest likelihood that medical treatment will prevent death by injury. In the battlefield, abdominal wounds are nearly impossible to treat as combat medics are unable to detect where exactly the injuries are or how to stop internal bleeding. In many cases, the only treatment capable of saving the service member’s life is to get them to a surgeon, which is not always an option.

In response, Arsenal Medical Inc. and The Defense Advanced Research Projects Agency (DARPA) are currently developing a polyurethane polymer foam which will control internal hemorrhaging and could dramatically reduce the amount of battlefield casualties due to internal bleeding. DARPA hopes that when finished, their foam will help the wounded survive during the critical minutes necessary while transporting a service member to a proper surgeon.

How does it Work?

The polymer foam is first injected into the abdominal cavity in two liquid phases – a poly phase and an isocyanate phase. When the liquids combine, they react and expand to 30 times their original volume. As the foam expands, it fills the intact abdominal cavity and hardens into a dressing that molds itself to the internal organs and resists blood loss. The military had tried similar foam-based solutions in the past but to no success as many of the foams stuck to tissue and mixed with moving blood. DARPA’ s new foam is capable of being removed in nearly one piece and in less than one minute after the surgeon’s initial incision. The foam does not adhere to tissues and only mildly absorbs blood on its surface.

Results

In order to test the foam, Arsenal Medical Inc. chose to work with swine as their anatomy and size of organs are similar to that of humans. Researchers found it critical that tests were performed in closed cavities which many feel is a concept that is as revolutionary as the foam itself as it has never been done before. In their tests, Arsenal Medical Inc. found that pigs died within 30 minutes without intervention. With their foam, 100 percent survived an hour and 72 percent survived for close to three hours. While DARPA’ s foam has yet to be approved for human testing, the results are promising and have many extremely excited at its potential. Arsenal recently received a $15.5 million Phase II contract award and will be entering the FDA application process soon in hopes to eventually begin human testing.

Attachments: Stasis Foam Set for the Battlefield

3D Bioprinting

New Advancements: Exploring 3D Bioprinting

3D BioprintingEvery few generations an invention is created that changes the course of humanity. The printing press changed the way we spread ideas. The industrial revolution altered the way we produce goods. Now, our generation’s paradigm shifting invention is upon us and it goes by the name of 3D bioprinting.

Why is 3D Bioprinting Important?

3D bioprinting is thrilling because of its potential to develop living human tissue which can be used for clinical trials and to ‘treat’ patients. Specifically, recent advances have enabled 3D bioprinting of biocompatible materials, cells, and supporting components into complex 3D functional living tissues. 3D bioprinting is also being applied to regenerative medicine to address the need for tissues and organs suitable for transplantation. Creating viable 3D printing models of human tissue and systems may lead to more effective drug development; however organ and tissue structures vary in complexity and printing with living cells is challenging.

Compared to non-biological printing, 3D bioprinting involves additional complexities such as the choice of materials, cell types, growth, differentiation factors and technical challenges related to the sensitivities of living cells and construction of tissues. Several companies have recently announced their decision to explore 3D bioprinting, which certainly could provide a cheaper way to test its products for toxicity and efficacy. Organovo is working with a number of pharmaceutical and biotechnology companies to further their research. Proctor & Gamble recently launched a giant competition in Singapore asking academics to submit proposals on 3D bioprinting applications. The advantages seem obvious however it is simply too early to place that ‘flag in the sand’ and deem 3D bioprinting as a definite solution without conducting extensive research.

How Does Bioprinting Work?

Bioprinting works by taking cultured human cells and forming bio-ink, a material made from living cells that behaves much like a liquid. This allows people to “print” it in order to create a desired shape (1). Bio-ink is then placed into cartridges that contain a syringe, fitted with an extrusion nozzle for printing. Next, the bioprinter deposits a pattern of cells in layers, interspersed with a water-based gel known as hydrogel that is then used as a kind of scaffolding for the cells. Lastly, the printed tissue is left to grow naturally and the hydrogel is removed.

Conclusion

This initiative is one of many in the pharmaceutical and biotech industry that is being evaluated in an urgent quest to speed up drug development and lower costs. While there are many challenges, it may only be a matter of time before the far reaching drug testing approach of 3D Bioprinting will be the new standard for testing chemotherapy drugs and oral contraceptives.

Attachments: 3D Bioprinting

Ambulance Drones

Ambulance DronesA bright young engineer in the Netherlands named Alec Momont has developed a concept that could potentially transform the face of emergency medicine using one of the most popular technologic advances—drones. Momont has developed an “ambulance drone” equipped with a defibrillator to increase the survival rate of heart attack victims who experience heart attacks outside of the hospital.

Current statistics do not reflect a promising outcome for victims of cardiac arrest outside the home. Brain death due to cardiac arrest typically occurs between 4 to 6 minutes after the incident, while the average ambulance response time sits at 10 minutes. This has led to a heart attack survival rate of only 8 percent. The use of ambulance drones to speed up emergency response time is ingenious because of their ability to bypass traffic and reach victims anywhere in a 4.6 square mile radius in 1 minute, thus cutting response time significantly. Momont claims that his drones could increase heart attack survival rates from 8 percent to 80 percent. This, amongst other factors, exemplifies how drones are a positive solution to existing problems in emergency medicine.

”It is essential that the right medical care is provided within the first few minutes of a cardiac arrest,’ says Alec Momont. ‘If we can get to an emergency scene faster we can save many lives and facilitate the recovery of many patients”.
–Alec Momont

Drones also cut costs because they do not require gas and maintenance the way ambulances do, nor do they require paramedics. However, legal hitches have hindered the commercialization of the product as drones are not permitted to fly remotely in the Netherlands. Ultimately, if this product gets the go-ahead, Momont hopes to implement the idea of an emergency drone to deliver quick help in other situations like oxygen masks during a fire or insulin when someone goes into diabetic shock. This creation has the potential to effectively save thousands of lives if it gains the support it needs.

Attachments: Ambulance Drones

Rapid Success! – Fast Timelines for Clinical Trials

Timeline TextTime is money! We have all heard this age old expression, but PharPoint Research takes this message to heart. Time is often a client’s most limited resource, which is why PharPoint works diligently to deliver results faster than our competitors. The images below outline the fast timelines for a typical PharPoint study

Click Here to See PharPoint's Standard Timeline

Timeline

Attachments: Rapid Success!

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Outsourcing Clinical Trials

PharPoint Research has an excellent reputation in effectively managing clinical trials, but what has made us unique is our ability to identify and focus on the areas where we are truly exceptional, and partner with outsourced clinical trial service providers to perform services outside our core expertise. This self-aware approach has allowed PharPoint Research to grow from a boutique consulting firm into a dynamic and strategically focused company.

Attachments: Best of Class Model

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Consider the ‘Five Fs’ When Choosing a CRO

F

We all know experience, teamwork, and industry know-how are key qualities to consider when choosing a CRO. But when you want the best CRO for your clinical trial, it might be easier to think of the five Fs: forward thinking, fast, familiar, fit, and flexible.

Attachments: Consider the ‘Five Fs’ When Choosing a CRO

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PharPoint Research wins project award from Otologic Pharmaceutics

North Carolina-based CRO, PharPoint Research, today announced their award from Otologic Pharmaceutics for a full service, Phase I clinical trial assessing the safety, tolerability, and pharmacokinetic profile of agents in the treatment of hearing loss.

“Hearing loss is the third most common physical ailment behind arthritis and heart disease,” noted Audra McRae, PharPoint’s Chief Operating Officer.  “Using our team’s experience we are excited to work on a product that potentially eases the troubles for those affected by hearing loss.”

Despite efforts to protect and preserve hearing, nearly 9 million Americans suffer from some degree of hearing damage caused by noise-induced hearing loss (NIHL).  There is a short timeframe to minimize the damage caused by a NIHL and this clinical program seeks to prevent permanent hearing damage through an oral regimen taken during the initial days after the noise trauma.

Otologic selected PharPoint Research for this initiative based on the organization’s extensive experience in Phase I trials, as well as their flexible and responsive management approach, tailored specifically to the trials’ needs.   Recruitment for the study is expected to begin in the third quarter of 2014.

SCOPE conference
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PharPoint Research attending Summit for Clinical Ops Executives (SCOPE) in February

With our continued commitment to excellence in Clinical Operations, PharPoint Research will be attending the Summit for Clinical Ops Executives (SCOPE) Meeting in Miami, Florida on February 4–6, 2014. One of the featured tracks is “Integrating and Leveraging Clinical Trial Operations Data”, which is an area for the company. Please contact us in advance to set up time to speak with one of our representatives and let us explain how PharPoint Research is “the better way”.