Clinical Trials2019-12-16T20:43:56+00:00

Absolutely Unique & Substantially Superior

More Than Subject Recruiters, We Are Patient Advocates

Our team was built from the ground up with the purpose of finding and supporting advanced Parkinson’s disease patients seeking additional treatment options.

  • Medical Direction– integrated and highly involved collaboration with a movement disorders specialized physician enables unparalleled advantages.

  • Educated Advocates – our in-house team of professionals hold scientific collegiate and postgraduate degrees and are trained at our movement disorders clinic and research site.

  • Data Aggregation Team- our offshore clerical team identifies massive highly targeted audiences for ad delivery which assist in the targetting of appropriate patients when automated processes are not available or sufficient.

  • Technical Capabilities– substantial experience specific to the development of resources such as websites, social media groups, social media advertising assets, digital delivery techniques, secure patient communication tracking systems, and the secured collection and processing of patient health information specific to movement disorders (primarily Parkinson’s disease). Our technology providers include specialists in the development and management of HIPAA secured infrastructures, algorithmic decision modeling and process development, analytics and tracking, and objective oriented user interface design.

  • Ethics & Compliance– exceptional team including industry-leading lawyers with direct access to leadership within the FDA, experienced physicians/principal investigators, renowned internal review boards with access to thought leaders publishing guidance documents on the ethical use of technology in healthcare, and innovative technologists consistently improving the functionality and security of our digital infrastructure.

What do we do that is above and beyond the competition?

Them Us

Movement disorders specialized staff

Review of informed consent by phone with candidate

Detailed screening directly corresponds to the Inclusion/Exclusion Criteria

Phone interview to determine candidate suitability

Principle Investigator Doctor to Doctor capability to discuss candidates

Specifically designed media assets for advanced Parkinson’s disease

Developed database with hundreds of highly likely candidates

Ad campaigns developed specifically for individual trials to engage with the target group (e.g. de novo patients, patients with motor fluctuations, patients with troublesome dyskinesias, etc.)

Telephone warm transfer of most valuable leads to site coordinators

Extensive recruiting experience for PD patients

Fair, balanced and broad phone based advocacy program

Largest PD Facebook Support Group in the world

Over 50,000 monthly pageviews on a PD patient facing website

Medical record acquisition

Optional

Medical record review

Optional

Delivery of patient medical records to sites

Optional

Question: Are all doctors the same?

Of course not. Some are specialists some are a generalist. Some doctors are excellent, some are good and unfortunately a few are bad.

The same can be said about digital marketers and subject recruiters. We are excellent digital marketers and patient advocates specialized in clinical trials recruitment for Parkinson’s disease patients. There was a time that Search Engine Optimization and Search Based Marketing was the best digital tool for online communication. That is no longer true for subject recruitment. Search based marketing waits for the patient to research a trial online or begin searching keywords associated with their disease state. Profile-based marketing enabled by social media, allows us to engage patients when they are online doing anything. They could be watching kitty cat videos or messaging a friend when our messages are displayed. Because we are laser-focused on the serving the PD community, we can identify nearly 1 million people in the US that are strongly related to the disease (primarily patients and caregivers.) Our methods of communicating with candidates are absolutely unique and superior.

Search Based

Google

Search Based Advertising

This method requires the patient to come to you by searching for a keyword. This is useful but very limiting.

Profile Based

Facebook

Social Media

Targets profiles, not keywords. You go to the patients to deliver the message opposed to waiting for them to ask the question.

47,600,000 Facebook users over the age of 55 in the US as of January 2018

Approximately 92,800,000 people in the US are over the age of 55

Database of interested prospective subjects which can fill many Parkinson’s disease related clinical trials.

Research Catalyst has a substantial database of PD patients that is rapidly growing. The data collection process has been tailored to accommodate anticipated clinical trials. Through the brand Parkinson’s Community Research Catalyst delivers  millions of advertising impressions to hundreds of thousands  unique people associated with PD in the United States.  This generates over fifty thousand web visits each month and a database of nearly twenty thousand people that have answered a clinical trials prescreener with over a hundred specific qualifying questions pertinent to most PD clinical trials I/E criteria.

By The Numbers

Hundreds of candidates that meet even the strictest inclusion and exclusion criteria for most PD trials

Nearly 20,000 PD Profiles Acquired

1 Million  Unique Viewers

Millions of Impressions

Access These High-Quality Profiles

Look at the quality of the candidates in this database as each question is designed to determine the eligibility of candidates based upon the inclusion and exclusion parameters of PD related clinical trials.

Q: What is the patient’s diagnosis?

A: Parkinson’s disease

A: Is not Atypical Parkinson’s disease

The ability to enter a trial through third-party recruitment opposed to being placed by their physician indicates that it is probable that either the patient or the patient’s caregiver has the capacity to complete diary entries accurately.

Q: If the patient elects to be in a research study do they have a spouse, caregiver, or friend who lives with them that could help with study participation and could attend some study visits?

A: Must be yes.

Q: Can the patient tell when the levodopa/carbidopa wears off?

A: Yes

Note: The ability to enter a trial through third-party recruitment and complete our questionnaire as opposed to being placed by their physician indicates that it is probable that either the patient or the patient’s caregiver has the capacity to complete diary entries accurately.

Q: Has the patient been diagnosed with dementia or have significant trouble with memory or thinking that affects day to day activities (i.e. cognitive impairment)?

A: Must be no.

Q: If the patient elects to be in a research study do they have a spouse, caregiver, or friend who lives with them that could help with study participation and could attend some study visits?

A: Must be yes.

Q: The patient has been diagnosed with:

A: Parkinson’s disease

Q: Does the patient currently have or in the past had hallucinations (e.g. seeing people, animals, or things are not truly present) or delusions (fixed unusual thoughts such as paranoia)?

A: Must be no.

Q: Does the patient have either of the following psychiatric conditions?

A: Must not be psychosis.

Q: Does the patient have a history of recent significant cardiac problems: heart attack within the last year, bypass surgery in the last year, pacemaker placement in the past year?

A: Must be no.

Q: Does the patient have kidney dialysis or has their doctor diagnosed them with any acute or chronic renal insufficiency or failure?

A: Must be no.

Q: Does the patient have liver insufficiency or been diagnosed with liver disease?

A: Must be no.

Q: Is the patient taking or have they previously taken the following medications? (Apomorphine (Apokyn))

A: Must be no.

Q: Is the patient currently using any cannabis products (Medical or Recreational) by smoking/ vaping. Edibles, or topicals to skin?

A: Must be no or Yes, but willing to stop.

Q: Has the patient been diagnosed with addiction or treated for use of any addictive drug (e,g, opioids/ narcotics. methamphetamine, cocaine, etc,)?

A: Must be no or over 1 year ago.

Q: Has the patient been diagnosed with or treated for excessive alcohol use (alcoholism) in the last 2 years?

A: Must be no or over 1 year ago.

Q: Is the patient currently participating in a clinical trial?

A: Must be no or non-interventional.

Q: What best describes the patient’s dyskinesia (excess involuntary movements that are squirming or rocking, writhing, that occur when your medication is working or at too high a level)?

A:  Must [not] be: It is a big problem.

Candidate Profile Example 1

Candidate Profile Example 2

Phone Screening

These questions typically require more advance review by our staff trained in movement disorders clinical trials including research coordinators and a principal investigator.

Rarely exclusionary and we no longer ask this question but in the past, we asked if the patient could walk without the assistance of a cane or walker for a short distance. Over 99% of respondents meet this criterion, so this question will be asked over the phone.

Q: Has the patient been diagnosed with cancer?

A: No

IF yes THEN:

Q: When was the patient diagnosed with cancer

Answer: IF less than 5 years THEN

Was the cancer malignant?

IF no THEN phone screen to determine eligibility and examine medical records.

Q: Within the past two years has the patient taken antipsychotic medication? (e.g. Seroquel/ quetiapine, Nuplazid/ pimavanserin, Clozaril/ clozapine, Risperdal/ risperidone, Zyprexa/ olanzapine)?

A: If yes determined by RC medical director.

Experience motor fluctuations and experience an average of at least [2] hours daily in the “OFF” state during the waking hours as confirmed by adequately completed baseline home diary.”

Q: Does OFF time interfere with day to day activities or quality of life?

A: Initial screening answer must be yes.

Q: Can the patient tell when the levodopa/carbidopa (Sinemet or Rytary) wears off between doses or kicks in such that the patient has some time during the day when the medication is not working and the patient is functioning less than optimally or slowly?

A: Initial screening answer must be yes.

Q: How many times/day is the patient taking Sinemet or Rytary?

A: Must be Sinemet 4 or more or Rytary 3 or more times per day.

Q: Is the patient taking or previously taken any additional antiparkinson medication such as Azilect/rasagiline, selegiline, pramipexole/Mirapex, ropinirole/Requip, rotigotine/Neupro, entacapone/Comtan/Stalevo, tolcapone/Tasmar?

A: Must have taken or be currently taking 2 of the 4 classes of medications (COMT, MAOB, Dopamine Agonist, Amantadine)

IF they successfully answer these questions THEN

“OFF” period timelines are conducted during a phone screening by our trained staff members. We timelined 18 candidates and found that every one of them reported more than 2 hours of akinesia. See the results below.

Capability to identify troublesome akinesia.

Research Catalyst’s Patient Advocates conducted a study to determine if the online questions above adequately selects patients that will timeline appropriately at screening for akinesia.  18 consecutive candidates that answered the above questions affirmatively timelined for OFF time severity of akinesia well over 2 hours on their average day.  This process takes approximately 45 minutes per candidate as the patient is guided through the day and detailed information is acquired to accurately account for dose time, amount, akinesia and dyskinesia. The results are summarized in this chart.

Determined by Sites Research Coordinator and Principle Investigator

  • Subjects must be on stable doses of all their anti-PD medications for at least 28 days before Baseline (Day 1).

  • Female subjects must be surgically sterile (hysterectomy, bilateral oophorectomy, or tubal ligation), postmenopausal (defined as cessation of menses for at least 1 year), or willing to practice a highly effective method of contraception…

  • Willingness and ability to comply with study requirements.

  • Subjects with a clinically significant or unstable medical, surgical, psychiatric condition or laboratory abnormalities which, in the opinion of the Investigator or our Enrollment Authorization Committee, represents a safety risk, makes the subject unsuitable for study entry or potentially unable to complete all aspects of the study.

  • Subjects treated with anti-PD medications that need or are anticipated to need dose adjustment in the 4 weeks before study Baseline or during the course of the study.

Born from a Research Site

We understand the challenges faced by sites.

We get better site participation because we work differently and do much more. We understand that most sites hate working with central recruitment companies that just waste the time of coordinators and send lots of useless candidates to the site. We only send a few highly qualified candidates to sites.  These candidates live close to the site and are highly vetted. Most should be ready to bring in for screening. Our Medical Director (a PI himself), will reach out to the principle investigators at each site to facilitate engagement with the PI’s and their research coordinators and will educate them about our processes about how we work differently than other central recruitment companies.

Performing Well For Clients

Through Doing Right By Patients

Advocacy Process & Service

The Advocacy Program

  • One on One Education
  • Phone Screening and Overview of ICF
  • Fair and Balanced Information
  • Warm transfer to Site Coordinators
  • Follow Through To Randomization
The advocacy program works. We historically reach 80% of high-quality candidates by phone within 45 days.

Leverage Social Media & Algorithmic Decision Modeling

Digital technology and social media provide new tools to identify and communicate with patients in extraordinary ways. We can now broadcast and interact almost exclusively with very narrow targets, such as people who identify with advanced Parkinson’s disease. We can focus our advertising dollars towards these patients and their loved ones and do not need to expend advertising dollars to deliver messages to a non-applicable audience. Social media opportunities not only offer laser focus but also massive broadcast. Facebook recently celebrated 1 billion active users in a single day. Through the proper use of social media advertising, Research Catalyst can reach nearly 1 million people in the U.S. who identify with Parkinson’s disease as either a patient or a caregiver. HIPAA compliant technology has also advanced to the point that algorithmic decision models can collect patient health information with extreme efficiency. Research Catalyst has developed a process that automatically collects up to 108 pieces of information from a patient as they answer questions to identify their suitability for investigational and approved treatment options. Through technology comes efficiency, and as a result of a more focused and automated screening process, extensive resources can be delivered to the right patients once they have been identified.

Compliance Is Just The Start

We do more than follow the rules; We work with the people who make them and embody their intention. The regulatory environment concerning the use of social media for the promotion of pharmaceuticals is complex. A comprehensive understanding of not only the rules but also the intention of the law is imperative. Research Catalyst approaches the ethical considerations of patient education and marketing from a patient first perspective. All information provided must be accurate, truthful, complete, fair and balanced. The industry standard of fair balance for post FDA marketing generally includes an accurate representation of the indicated use, proven benefits, and potential side effects. We abide by the rules established to govern FDA approved marketing campaigns and adhere to a stricter and more comprehensive set of guidelines designed for the medical research community. The set of principles most relevant to this discussion is, of course, the informed consent process. This ethical framework not only requires accurate and balanced information about a treatment option (indications, potential benefit and risks), but most notably incorporates education about other suitable opportunities the patient should consider that are not associated with the sponsored treatment. Broadly educating the patient about reasonable options such as support groups, exercise, physicians in their area, and other treatment opportunities not only protects our sponsors but also gains the patients’ trust as we prioritize their wellbeing before our financial incentive. We are not only doing what is compliant but also what is right.

This methodology goes beyond what is required by law and actualizes the governing bodies vision as it relates to the incorporation of digital media to the patient education process. By placing the patient first and understanding both the laws and their intentions, Research Catalyst establishes the security to leverage internet technology with unprecedented results. We distance ourselves and our clients in this way from the bleeding edge and stay firmly at the cutting edge. By educating patients broadly, we earn their trust and our message is heard. Integrating the most ethical practices with the most sophisticated technology can produce the greatest reward for both the patient and the organizations that support them.

Resources & Capabilities

Social Media’s PD Audience Size in the US

Research Catalyst has mapped nearly 1 million people in the United States in to a Parkinson’s disease cohort through Facebook and Instagram and communicates with this population in a big way.

  • Over 1 Million People Reached

  • Hundreds of Thousands Impressions Monthly

  • Tens of Thousands Engagements Monthly

Largest PD Support Group on Facebook with over 16,000 Members

We own, administer and moderate the largest Parkinson’s disease group on Facebook.

  • Market Research

  • Branding and Awerness

  • Advertising & Direct Communication

This group is an excellent resource that builds trust and allows us to conduct market research quickly.

Visit Group

Parkinson’s Community Website

We own and operated one of the most sophisticated advocacy and recruitment websites online.

  • Comprehensive Educational Resource

  • IRB Approved Material

  • Responsive Design (mobile friendly)

  • HIPAA Compliant Security

  • Smart Algorithmic Screening

  • Advanced Analytics

Visit Website

Qualifying Patients By Region to Support Site Initiation Decision Making

We can target communication to people within range of sites and also help prioritize site initiation based on where identified candidates live.

National Campaign with an extensive travel budget warranted a complete contiguous U.S. targeted campaign. These dots represent the locations of candidates that were appropriate for this large multi-site trial with travel services available.

This map shows candidates in blue and site locations in orange for a different trial that requires subjects to live very close to the study site illustrating the ability to precisely target both psychographically and geographically.

Payment Options

Campaigns can be run concurrently with other recruitment efforts or stand alone. With limited upfront investment required, you can safely increase the chance of completing recruitment on or before schedule with very little exposure.

Estimated Pricing: $5,000 per screen (pricing may vary)

Optional Add On Services: $150 per complete set of medical records, $200 per physician review of a candidate.

  • HIPAA compliant digital infrastructure
  • Call center services
  • Online medical record release form capture
  • Automated responsive online pre-screener

Estimated Pricing: $50,000/month

The all-inclusive plan is paid in advance every 4 weeks. This is a stable payment option that mitigates variable cost and always stays within budget. The client is in control to cancel at any time, so we are motivated to not only perform but to keep you updated and informed.

Plan includes all setup and operating costs such as advertising, infrastructure and staffing:

  • HIPAA compliant digital infrastructure
  • IRB reviewed and approved advertising
  • Marketing budget and campaign management
  • Call center services
  • Online medical record release form capture
  • Automated responsive online pre-screener
  • Physician review of candidates for placement

Hiring Process

A mutual agreement to respect one another’s confidential information is signed by both parties.
Review of this presentation and either a conference call or face to face meeting.
Client completes a questionnaire to facilitate the development of a statement of work and establish the foundational knowledge required to begin work.
The statement of work will define the initial project while the Master Service Agreement structures the relationship between Research Catalyst and the client. Work order for pilot projects are also an option for a faster launch.
A third party will review the entirety of the contract to ensure regulatory compliance and if necessary a fair market valuation is conducted to certify appropriate pricing.
Research Catalyst will begin work!
Request A Proposal

Exceptional | Compelling | Reliable