- Repurchase is the key to all of your marketing efforts and dollars
- It’s a unique marketing tool enabling you to connect directly with your customers
- Nothing speaks better to a customer than his own experience
Medicus Research engineered SysteMedicus™ technologies to visibly prove accuracy and compliancy through a real-time recording on Apple® iPads and iPods. It is designed to provide advanced data management, validation and authentication for an array of businesses.
The SysteMedicus™ patent pending, Apple®-based technologies also have specific innovative platforms developed for the medical and clinical trial communities, including clinical trial consent, clinical data acquisition, subject study product dosing, and subjective e-diary entries. They include (1)EduConsent™, (2) eCompliance and (3) eSource. These state-of-the-art platforms all ensure that the information is collected according to the FDA ALCOA standards (accurate, legible, contemporaneous, original, and attributable). This includes enhancing and documenting the informed consent process, and documenting accurate compliance of participation in the study by imaging, facial recognition with time/date stamps, and video interaction on mobile/hand held devices.
SysteMedicus™ custom-designed platforms – for business, for medicine … for a better tomorrow today!
Have you always wanted to be closer to your customers? Wellness Apps can do this for you – and a lot more!
SysteMedicus™ Wellness Apps, created by Medicus Research, are a one-of-a-kind suite of mobile applications designed for you to give to your customers through the Apple App Store.
Every day, your customers receive an alert reminding them to take your product and asks them to answer a few simple questions about its efficacy. By recording their own experiences with using the product, and seeing the application’s result-tracking graphs, they will know how your product is working for them and will want to keep using it.
Whether you’re a manufacturer, distributor or retailer, the Wellness Apps are branded for each company that licenses them. Using the same tools and mechanisms that Medicus has used for many years in their clinical trials, the apps are customized based on a product’s structure / function claims.
These mobile applications provide your company with an innovative marketing tool by bringing daily branding to customers and sending them product-specific notifications, including company news and announcements, special promotions, coupons and more.
The Wellness Apps are unlike any health and wellness applications currently on the market because they’re created and supported by Medicus Research, the premier research organization for the natural health industry. No other application developer has the extensive background to offer such a meaningful, scientifically and medically valid, user friendly mobile application as the Wellness Apps.
Why promote your product from a distance, when you can now open the door to your customers? The keys are efficacy tracking, branding frequency, customer engagement, compliance and repurchase loyalty.
Custom-designed electronic consent
Respecting the participant. Protecting the provider. Modernizing the consent document, so it’s not just signed – but understood.
Tradition meets technology to make your practices more contemporary and professional, efficient and ethical. Legally solid informed consent like nothing you’ve ever experienced. Conceived from need – born to break the mold.Informed consent – incredible change!
Unique FeaturesThe use of consent documents is well-known and widespread in many industries, businesses, environments and situations. Most commonly, it plays a familiar and vital role in the area of medical treatment and research.
The association between a doctor and patient is not only a relationship based on confidence and trust – but it is a highly charged ethical and legal relationship as well. The legal aspect is most significant whenever a medical procedure or intervention is involved – whether for health needs, elective courses of action, or as part of a research study.
Informed consent requires that all patients (or research study subjects) fully understand what will be happening to them and agree to the potential outcomes. There must be a clear knowledge and appreciation of the facts, implications and consequences of what is to take place.
In the United States, all 50 states have enacted legislation that requires some level of informed consent. A doctor and medical or research facility are liable for negligence and malpractice if they fail to obtain proper consent.
How It Works – EduConsent™ Step-by-Step STEP 1The practitioner selects the appropriate informed consent on the tablet, takes a picture of the participant, and enters their information.
STEP 2The participant watches a brief custom-made video (optional for EduConsent™ client) about the service / procedure / intervention, while being video recorded themselves by the iPad mini. A time/date stamp is applied along with an elapsed time counter.
STEP 3The participant then reads the informed consent on the device (while still being video recorded by the device). The informed consent itself is broken up into small and readable text blocks. When the reader is ready to turn the page, they must answer a question about what they just read. If they get the answer incorrect, the system will take them back to the text and highlight the relevant segment.
STEP 4When the participant has completed reading the consent and answering each of the questions correctly, the practitioner or administrator can then step into the room and answer any questions the participant may have. The practitioner is now video recorded while answering these questions. When the discussion is complete, the participant (who is now being recorded) confirms that all of their questions have been adequately answered and that they are ready to sign the consent.
STEP 5 The practitioner and participant sign the consent on the tablet electronically. STEP 6The entire consent process (including time/date stamp, participant picture, participant data, answers to all of the questions, and the video of the entire encounter) is uploaded to the SysteMedicus™ servers and the consent and signatures can be printed for the client’s files.
EduConsent™ …
Tradition Transformed By Tomorrow’s Technology
The subject is shown multimedia content regarding the medical procedure or clinical study in order to enhance comprehension and retention.
Unlike paper consent, EduConsent™ can be customized for each procedure and individual. It can instruct in different languages, and the size of the text can be increased for easy reading or read out loud text-to-speech mode can be initiated.
EduConsent™ is interactive, so there is proof that each page was read. The participant answers an interactive quiz to confirm their awareness and understanding of the information. It can also be set up to record a patient’s questions and the practitioner’s answers. Using facial recognition technology, along with a magstripe identity card and signature capture, the subject will authenticate their consent.
Finally, another nice feature of the EduConsent™ system is that it integrates with the SysteMedicus™ eCompliance and eSource systems.
Electronic evidence-driven verification
When Value & Results Rely On Verification You Want the Latest, the Brightest, the Best! Bring On the SysteMedicus™ eCompliance™ Platform…
Beyond Compare.
How do you guarantee something is true, real, and accurate? By being there.
eCompliance™ takes you there to remotely, unmistakably witness, record and capture compliance as it happens. Providing complete, undeniable substantiation, this inventive new product promises foolproof results every step of the way in any situation with every need.
SysteMedicus™ has engineered, specifically for researchers, doctors and other professionals, a dynamic state-of-the-art Apple® iPad-based electronic verification system like no other!
If a tree falls in the forest … eCompliance™ hears it, sees it, documents it – loud, clear, compliant.
Compliance refers to the willingness and degree to which a participant in any circumstance follows a well-defined set of instructions.
In clinical trials and medical practice, compliance refers to the extent to which a subject or patient properly follows the prescribed code of conduct or course of treatment from a researcher, clinician or doctor. (The term concordance is also being used to describe the fulfillment of directives.)
Most commonly in medical and research study situations, compliance means following a regimen of drug or study product intake – the correct dose at a defined time daily and throughout an agreed upon specified period. It also often refers to adherence to required alterations in behavior, including dietary and activity restrictions.
In clinical trials, compliance is an important factor with regard to the outcome and significance of any given research study. In the area of medical prescriptions and therapies, lack of compliance can result in treatment being unnecessarily extended or health conditions not being remedied.
When the legitimacy, success and impact of an action, set of guidelines or directive (in a study, medical protocol, project or other need) relies on participants accurately following instructions, reliable compliance substantiation is critical.
While compliance is not expected to be 100 percent perfect, it is generally necessary for guidelines to be followed within a certain acceptable set of parameters.
The actual or perceived value of a body of work and results claims will be reduced or rejected if it cannot be proven that the participants performed the requirements correctly and precisely. Despite all of your planning, the ranking of your business, the credentials of your staff, and your past accomplishments, without the use of contemporary, indisputable compliance confirmation, your objective and reputation are at risk.
In the clinical trial and medical research environments, patient noncompliance is a major factor in misleading, questionable or failed results. With governmental oversight expanding, investigational reports from the media on the rise, and competitors clamoring to expose their opponents’ weakest links, the ability to demonstrate accurate results has never been more imperative. Without infallible compliance, all can be lost – most importantly, your reputation.
User Steps STEP 1 : User Login
STEP 2 : Study Product / Barcode Scan or Capture (Photo of Barcode)
STEP 3 : Dose Compliance
STEP 4 : Diary Collection
STEP 5 : Compliance Calculation
Administrator Setup
STEP 1 : Administrator Login
STEP 2 : Main Menu (Add New Subject / Create Schedule / File Sharing / Set Up Server)
STEP 3 : Dose Compliance
STEP 4 : Diary Collection
STEP 5 : Compliance Calculation
The SysteMedicus™ eCompliance technology is a revolutionary method of confirming a patient’s or subject’s compliance with requirements for medical care or participation in a research study by recording product consumption and data collection. This electronic informed consent platform helps to eliminate the potential for inaccuracies caused by human error and lack of off-site monitoring of participants.
Subjects will receive compliance alerts every day at the time they are required to take their study product. Those who are not taking their study product at the required times/dates will be easily identified.
For the first time, clinic staff, study sponsors and regulators can see if the patients/subjects are compliant by actually watching them take their study medications.
Paperless/Portable Data Administration
Technology and Innovation Generating A Custom-designed, One-of-a-kind Electronic Platform for Source Material.
The New Standard in Data Collection.
In the contemporary, competitive global landscape, a company’s ability to survive and thrive depends on its ability to integrate new technologies.
A goal and vision to reinvent and transform the traditional is what lead the way for the creation of the SysteMedicus™ eSource. This exclusive Apple® iPad-based data collection hardware/software system was inspired by industry needs and was intelligently engineered primarily for operational use in clinical trials.Paper Passé.
eSource… Transforming the Everyday!
The FDA provides guidelines for Source Documents. In part, they are described as: Original documents, data and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects’ diaries, data from automated instruments, x-rays, etc. involved in the clinical trial). Source Documents include all information in original records and certified copies of original records or clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. The Source Document includes everything.
Data from the Source Document is entered into the Case Report Form. The CRF highlights the study endpoints; its information encapsulates the pertinent data in the Source Document. After each subject visit, the clinic transfers relevant information from the Source Document to the Case Report Form. The CRF is the primary document used to analyze the research study and is used to create the final report of findings.
While the CRF is actively utilized as the key document, the Source Document is an essential record of all that took place and is a vital resource for substantiating the endpoints.
Traditionally, everything that occurs in a clinical trial is entered into the Source Document through archaic handwritten notes or standardized, cookie-cutter administrative software by any one of a number of staff members (clinician, nurse practitioner, clinical research coordinator, clinical research assistant).
There is no login, no time/date stamp, no computerized checks and balances, no alert system, no automated reminders, no electronic retrieval, no interactivity (the left hand doesn’t know what the right hand is doing).
Human error is endemic, documents are vulnerable, and the process is outdated.
Paperless, portable and customizable – eSource dramatically transforms data administration using state-of-the-art technology – hardware and software. It is proudly supported by the latest Apple® innovations.
eSource is an affordable, robust system for recording, managing and archiving clean data. It modernizes operations and is easily adaptable for specific and changing needs.
Beyond data collection, eSource engages data. Most importantly, it is designed to dynamically, proactively follow protocol every step of the way. Reminders and alerts are automatically prompted; procedures, guidelines and regulations are available to the administrator and managed with the help of the system. For example, if a study subject’s vital signs or lab work falls outside the inclusionary range of the protocol, the inputted source data will trigger an immediate alert.
eSource effectively delivers data off the page and literally puts control in the hands of the user. This is the future of data collection, management and storage available today through SysteMedicus®.
SysteMedicus™ eSource
Companies That Are Technologically Advanced Advance in Every Way.
eSource (electronic source documentation) is the new standard in data collection for clinical trials.
The SysteMedicus™ eSource platform is an Apple® iPad-based data collection hardware/software system for use by clinic staff and clinician investigators, which integrates data from the subject, investigator and wireless devices (mHealth).
Data is captured locally, can be printed wirelessly, and is uploaded to the server automatically.
The drugstore shelves are filled with similar looking products – dietary supplements, functional foods, and cosmeceuticals – all making the same wellness claims. Consumers face the same problem when shopping on the Internet. People are confused and have no clue about which one to buy.
What causes a person to choose a health and wellness product from one company versus a similar product from another? Of course, name recognition and price are most often part of the equation. The problem, however, is that these two factors don’t prove anything when it comes to product quality, reliability and results. The average customer cannot easily and accurately track whether or not the product they chose is working for them. They may haphazardly try one product one month and another product the next before finally giving up altogether.
When customers don’t have a way of knowing if a product is working for them, brand loyalty has trouble sticking, routine repurchases don’t form into predictable habits, and longevity suffers.
A product that is actually worth its value and lives up to its claims may not be recognized by potential new customers or given enough credit by existing customers if they cannot gauge the results.
Those companies with products that do enjoy customer recognition and satisfaction usually don’t have a good way of keeping in touch with their customers.
The Wellness Apps not only help to bring “personal wellness” to customers who purchase dietary supplements – they bring substantial “business wellness” to the manufacturers, distributors and retailers who provide the mobile applications to their consumers.
Wellness Apps allow your company to form extraordinary, ongoing communication with your customers and expand your consumer base. Barcode scanning allows you to send product line information, news and updates, special promotions, repurchase reminders, and coupons.
SysteMedicus™ Wellness Apps – Keep in touch with your customers.
The Problem with Traditional Consent
The legal consent process – whether in the doctor’s office, research clinic or any number of other industries and businesses – is critical, yet severely flawed.
In the medical environment, for example, the all-important informed consent practice is generally poorly performed. At present, informed consent is still seen as a regulatory chore – simply a piece of paper to fill out. The current system forces a burden on the patient to sort through medical/legal jargon, which is difficult to read and nearly impossible to understand. It’s also a burden on the doctor and staff, as they have to go through the time-consuming motions to ensure that the consent requirement is performed. Lengthy and fine print is ignored or glossed over. Both doctor and patient are hurried and stressed – so they focus on getting it over with rather than doing it right.
At the conclusion of the consent process, even though the document is signed, without any proof that it was properly reviewed and comprehended, the doctors, medical institution and others are vulnerable to negligence and malpractice lawsuits.
The most Common Problems with traditional informed consent documents and practices:
Three years in the making, with world class brainpower and visionaries driving its development, the paperless, pioneering EduConsent™ system is now available and being successfully utilized in medical and clinical trial settings. It can be custom designed and engineered for any environment that uses consent documents.
Cutting-edge technology and targeted problem-solving innovation join forces to fix and improve the informed consent. This is the solution to the outdated and defective paper consent.
New and accessible electronic devices, combined with inventive made-to-order software, are offering powerful, accessible and affordable tools for positively influencing ways of collecting and disseminating vital information, capturing/sorting/archiving data, performing analytics, and assisting administration.
EduConsent™ brings it all together to revolutionize the relationship between service providers and customers, doctors and patients, research sites and study subjects.
EduConsent™, our patent-pending Apple iPad® based system, solves the problems with traditional consent by transforming it from top to bottom and launching it into the 21st century. This popular SysteMedicus™ platform truly informs subjects about every aspect of what will be happening – communicating with them and “listening” to them with regard to the risks and benefits of their service or procedure. It protects patients and doctors by video recording the informed consent process and assuring that everyone is on the same paperless page.
EduConsent™ brings a Solution to every informed consent problem:
EduConsent™ – problem solved.
The long-established deficiencies when it comes to compliance issues can be summed up simply with this familiar quote from former U.S. Surgeon General C. Everett Koop: “Drugs don’t work in patients who don’t take them.”
Even a relatively small deviation in a participant’s actions and behavior from what they were instructed to do is considered a major problem.
When compliance relies on the honor system or on outdated monitoring methods, conclusions can be questionable. Unfortunately, the most recent advances in verification systems are lacking and still fall short of providing comprehensive assurance of compliance.
Whatever the causes for noncompliance might be – forgetfulness, laziness, carelessness, poor comprehension, misunderstanding, lack of organization, etc. – it is a well-recognized endemic problem that negatively impacts research, healthcare, and other industries. Lack of compliance and weak detection techniques can jeopardize outcomes and result in costly, inaccurate conclusions.
While in a private practice medical setting, it is sometimes possible to identify individual patients with doubtful compliance, it is much more difficult to gauge compliance in groups of patients, such as patients in a clinic or those participating in research studies. The techniques traditionally used for measuring compliance in these large environments are far from adequate; the conventional methods tend to overestimate, skewing results.
Even though research study visits, for example, usually take place in the clinic, the time spent actually participating in a clinical trial is primarily at the subject’s home or workplace. Subjects are therefore entrusted to take the study product properly on their own and to remotely report the study-related endpoints (known as patient reported outcomes – PRO).
Without technologically advanced, reliable, failsafe compliance systems in place, the outcomes are defenseless.
The most Common Problems with traditional compliance:
On a mission to build an advanced and infallible compliance system, our topnotch software engineers and innovators from around the world developed the one-of-a-kind SysteMedicus™ eCompliance platform.
Bringing together the latest technology vanguards, eCompliance captures all remote activity during a clinical trial (and other settings), including subject identification via facial recognition, product identity confirmation via barcode recognition, remote real-time monitoring, video recording of subject administering study product (time/date stamped), diary entries, compliance calculator, and more – all uploaded to a mainframe server, accessible in real-time to the client, data captured and archived for safe, long-term storage.
Even the most negligible departure in compliance is detected, so results are definite and defensible.
This state-of-the-art, paperless compliance system is custom designed for each client and study specifications. The system can include a step-by-step tutorial – and it can be activated in record time. Learn more.
eCompliance is the failsafe Solution to the compliance problem:
Old-fashioned data collection for Source Documents and Case Report Forms leaves much to be desired – especially in contrast to the advanced, electronic data capture of eSource.
Research clinics, medical facilities and businesses have conventionally dealt with data collection and document handling by means of conventional filing systems and basic organizational procedures.
While the tradition of Source Documents and CRFs is rooted as basis for clinical research conduct and analysis – the conventional way data and documents are collected and managed is becoming a thing of the past.
Advancements in technology – both software and hardware – can now revolutionize data/document practices in any setting and for every need.
eSource is cutting-edge, one-of-a-kind, and customized.
The SysteMedicus™ technology helps to eliminate the potential for inaccuracies caused by human error and lack of off-site monitoring of participants.
The SysteMedicus™ leading edge electronic system streamlines and protects data management.
The SysteMedicus™ products enable legally binding electronic compliance transactions accepted by government agencies and businesses.
Doctors and medical staff reduce time spent on outdated administrative practices and organization, allowing for more quality time with patients/subjects.
Regulatory oversight is improved and risk of malpractice is minimized.
Overall operational costs are reduced.
Competitive advantage is strengthened.
The Apple® iOS, which SysteMedicus™ chose as the foundation for its platforms, is exceptionally well-known with greater numbers of people internationally gaining experience with it. Additionally, Apple® is unmatched in providing an extremely intuitive user experience.
Our specialized product development team consists of a growing roster of professionals in Europe, Asia and North America. This dedicated group works 24 hours a day across multiple time zones on the further development and rapid advancement of the system. This impressive network of industry leaders includes top developers, executive producers, award-winning graphic artists, select database engineers and pioneering experts in state-of-the-art facial recognition and augmented reality.
