wearable

Wearables and eHealth devices for clinical studies

The clinical trials industry is changing. As an equipment provider for clinical studies, Clinichain identifies that the industry is operating more remote, more data-driven and becomes paperless. We experience an increasing amount of studies involving a wearable (wearables ) monitoring device and a connected app, through which patients can receive feedback from their researchers and site personnel. The personalized data generated by the app itself is used to read out clinical outcomes. Throughout this innovative approach, the journey from lab to patient will shorten. This means faster development of new medicines and treatments.
Wearables have the potential to overcome several challenges related to clinical trials. They improve execution by increasing patients ability to participate, they drive patient engagement, and create more opportunities for decentralized trial sites. Measurements can be done continuously and results in more reliable clinical result outcomes.

eHealth Devices Clinichain
Clinichain believes that remote measuring will be fundamental in the future of clinical studies and has done much field research on a suitable type of rental solutions for wearable and connected devices. After several years’ experience in clinical study field, we have selected the following wearable and eHealth devices suitable for clinical studies:

1. Connected digital scales
Over the years we have seen a growing demand from customers in having their digital scales able to connect to real-time statistical process control software and apps. With connected scales it is possible to perform on site monitoring of weight remotely.

2. Fitbits & medical watches
Our clinical validated fit bits track activity, heart rate, and sleep. Researchers track patients’ step counts as well as standard measures of performance status. For one of the metabolic studies, Patients are monitored during the entire study from distance. Real-time data capture all the above measurements. These devices help measure performance continuously when patients are away from the clinical sites, resulting in reliable study outcomes.

3. mHealth devices
Patients use mobile phones to acquire data through out a clinical application. For example, patients enter the level of pain during the studies. This will be read out centrally by the CRO and data manager. With this digital mHealth solution, patients don’t have to fill in paper questionnaires. Questionnaires can be collected centrally and analyzed from distance.

4. Wearable glucometers
Wearable glucometers can remotely monitor patients’ blood glucose levels between appointments and site visits. Individual targets can be set for patients, and an automated alert system will let professionals know when deviations occur. Results are ingested in a cloud storage environment by the sites personnel, benefitting diabetic studies.

5. Wearable spirometers
With the newly developed spirometers, linked to a smartphone, patients can be measured without cables. The wearable device converts exhaled air into a measurable signal. Afterwards, this device is linked to a disease management platform for both the patient and the care provider. Again, central reading of this respiratory data generates efficiency for the CRO.

6. Connected blood pressure meter
A blood pressure meter is one of the most traditional clinical study equipment. For clinical trials we have selected a high-end medical device that measures blood pressure remotely with clinical accuracy around the wrist. All physical and sleep activities are measured at home, which enables continuous monitoring at night. This virtual data is continuously visible and can be read out, resulting in a reduction of clinical site visits.

Clinical Trial Service
Biotech companies are facing more and more global logistics needs and local purchasing challenges for home trials. They need to ensure timely delivery at the homes of the patient. For clinical projects the CRO has a need to rent these wearables devices and let them be picked up after site closes down, compliant with the Sunshine Act. Timely re-supply service of ancillaries and disposables ensure studies continue smoothly without any delay.
Managing devices for home trials means the calibration process needs to be arranged ahead of deployment. With a sophisticated strategy for calibration exchange services, all on-site devices stay calibrated for the entire study, conform to the quality guidelines.
Tablets and mobile phones are needed globally to perform the clinical application, sites require a local Wi-Fi hotspot or 4G capability. To simplify the process, pre-configuration service will make sure sites receive ready-for-use equipment. For the safety of data integrity and the Sunshine Act, data recovery and disposal service will be needed after site closedown.
Sponsors request flexible and transparent rental solutions for these wearable and clinical devices, to help clinical budget stay on budget and adapt to early terminations of clinical sites.

Would you like to know how Clinichain can support your studies remotely and digitally? Feel free to contact us for an eHealth device solution and / or a global clinical equipment rental options.
We look forward to getting in touch!

Accurate budget management

Accurate budget management global clinical studies

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Goal: Tips for more accurate budgeting with clinical trials

Accurate budget management for global clinical studies.

It’s a common problem and an ongoing day to day challenge. What is? Managing accurate and effective budgeting for global clinical studies. With this article, we would like to leverage some tips and tricks we see our clients used to tackle positive or negative budget variances and how we as Clinichain facilitate with any challenge that might occur along this journey.

1. Be aware of fluctuation
Challenges occur most of the time straight after the budget is finalized and when the trial begins. As we are all aware, a clinical study normally doesn’t stick to it’s set time frame. Meaning, it could be delayed or run overtime. Did you know that only 10% of trials are finished on time? The other 90% is paying up to $35,000 extra per day, per trial. Factors of this delay could be an increase in sites, subject and site recruitment, delays on the logistics part while dealing with different geographies and many more. This could result in a changed total projected budget overtime. As a positive or negative budget variance can bring pressure on transparency of the clinical budget, Clinichain will support you and your team, setting the most accurate budget. How do we do this? For example, if we are looking at the rental of clinical equipment like freezers and centrifuges for global clinical studies, Clinichain will make sure there is an annual expected price change in logistics and equipment service projected in the budget. This will help you to always offer a transparent quote without unexpected cost during or after the study.

2. Expect the unexpected
As mentioned earlier, clinical studies are complex and have many variables, which in many cases result in unexpected situations. Make sure you think about a subject drop out, study staff that can change, patient recruitment delays etc. What are the positive of negative budget variances when delays or extensions of your study are suddenly arising when setting up your initial budget? Clinichain is able to support you with unexpected situations like this. Why? With our flexible rental solutions, we can provide clinical equipment whenever you need these. If you choose for this flexible solution upfront and a study ends earlier than expected, you can end the rental contract every month.

3. Patient recruitment and retention
Patient recruitment and retention is one of the most important aspects in a clinical study and requires resources. This includes staff time, generation of recruitment materials and investment in advertising via different channels to enlarge the awareness of the targeted demographic. Besides retaining your patients can be just as difficult, however not less important as this can lead to inadequate data and thus a more expensive trial. It’s very important and crucial to have a plan. Strategize first before you come into action. Evaluate your time, resources, and data gained from the last trials to revise your mistakes in order to tackle them upfront. It might help to ask yourself the following questions; how accessible can our patients reach our sites? With or without a disability? Who is our ideal candidate, what motivated him/her to participate etc. Clinichain does not yet have a direct impact on this challenge, however we see an upcoming trend moving towards more home trials. Stay close to us for more information on how we see this evolve and match our service due to changing defiances in the industry.

4. Helicopter view
Foresee every single step of a process in a given protocol. Here an example; You may have budgeted analyzing samples from a test kit. To do this you need to produce the kits as well. What we would recommend is to charge the given test separate from analyzing the samples. It can be helpful to organize the project budget in a time line format, considering every single activity or service and which party is involved, related to which charges. This will result in a better overview per single service and who is responsible. How we organize this: When we set up a budget for kit packing and clinical supplies for a clinical study, we collaborate together with the central lab which analyses the samples. Together with the central lab, we make an overview of the total budget to monitor the entire kit project for the bio tech company for a complete transparent budget. This will lead to greater clarity and budget transparency throughout the business.

5. Explain the difference between direct and indirect costs.
Make sure you classify your business expenses by making a difference between direct and indirect costs. Only then you get the best overview of your ‘fully-loaded’ costs.

You can make a distinction between direct cost per patient per study conduct costs, such as patient study assessments and reported outcomes, investigator and coordinator fees and more, or direct fixed costs per study level cost, such as personnel (internal and external), site, clinical supply cost, printing/paper and data costs. Then we also have our fixed indirect costs, time (upper management), facility overhead, administrative fees such as staffing, legal, financial, record storage and other. Clinichain supports ongoing while creating a transparent and flexible budget for your upcoming global study. With our Equipment Delivery Budget we make sure our clients are not dealing with any unexpected costs during or after their study.

Feel free to contact us for more information.

A Sneak peek into the mind of a clinical study expert

A Sneak peek into the mind of a clinical study expert

Building quality relations is highly important for Clinichain. To do so, we need to come to collective and open-minded core values with our employees, but also with the partners and clients we help out with global clinical equipment rentals. Next, to providing clinical equipment service for global studies, it is highly important to stay on top of developments in the clinical trials field. And to do that, we’ve interviewed a global study director of a fast-growing biotech company.

What is your best way for building relationships with sites?

From my point of view, it is impossible to fully outsource relationship management. From my experience, sites appreciate visits by sponsors at their institutes to get more detailed info on the science, the product and the development plan. In many cases, the CRO’s don’t have enough knowledge to explain the science. We do use CRO’s, but for a big part we are in contact with sites ourselves as well. We visit sites during the study at least once. Our company does invest a lot in investigator meetings and advisory meetings to make sure we are on the same page with the sites and the vendors. We do fully outsource the set-up of the investigator meeting to a dedicated event partner.

How do you select your vendors?

First, I determine the requirements of the study (small study with 1-2 countries and a couple of clinical sites, versus a global study). I am open to collaborate with small niche CRO’s in when the study allows this. I have three preferred (global) CRO’s I like to use for all my studies; A CRO with a niche expertise is for us the most interesting. I prefer to have a good experience and close relationship with account management and executives. This assures that my studies are taken seriously and get internal support when required. In any case, with every type of vendor we set up a bidding event to assure you get the best value for your money.
We choose the right vendor, tailored to the specific requirements of the study. It’s very important to have trustful local contacts. We can always outsource experts to the local sites, but prefer local people who know the culture and speak the local language.

What is your vision of setting up a clinical budget?

I have templates from the past that have been validated. These budget templates are from small niche CRO’s and from Top 5 global CRO’s.
We set up a bidding event with a small and large CRO and explore the difference. Every CRO has its own ways of budgeting, making the puzzle and learning from that. In the end, every vendor has the same type of budget cost during their study. Try to gather as much info as possible. I do research on micro-level to explore what the biggest cost drivers are, such as project management and site visits. Negotiate about the hourly rate of the vendors. You can always lower the costs by decreasing a number of resources. To make sure you offer a transparent quote, without unexpected costs during or after the study, set an annual increase. It can be helpful to organize the project budget in a timeline format, considering every single activity or service, which party Is involved related to which charges. In this case, you have a better overview per single service and who is responsible for it.

How can one build the right culture in a clinical department?

This is all about selecting the right people. People need to be entrepreneurial, hands-on, motivated. I prefer to work with people from previous companies or people who have been referred by people I trust. Also, don’t try to make your operations in your department too complex with rigid operational procedures. Too many procedures and discussions often result in study delays. Sometimes we experience that a CRO hides behind procedures, which makes them less flexible. Make sure there is a good mix of people: structured blue people and out of the box thinking yellow personalities. Of course, don’t miss out on the red and green personalities. Read more about this: https://discprofile.com/what-is-disc/overview/

What is your advice on managing a study?

Work with experienced people and understand that you are responsible, even if you’ve outsourced. Be on top of your study and challenge your CRO’s at all time. Ask why they do the things they do and measure them. Make sure you quickly respond to questions by your vendors to avoid delays and expect the same from them (commit on lead times). Make sure you get the overviews you need to oversee and manage. Don’t be afraid to make changes and make changes quickly with team members from the CRO side when a study is running behind.

What is important in data capturing?

Always use EDC, even in case of a small study. This saves our company lots of time. Invest in high-quality technology and don’t go for the lower cost EDC solutions. Decide this together with a clinical data expert and ensure that data is as accessible as possible. Always think about the site perspective when choosing the right system for your type of study. Make sure the reporting system is safe and 100% clear. Don’t forget to make the data management consistent. The best way to achieve this is to have a standard data collection tool that you use for all your studies.

Do you want to learn more about how we deal with these aspects of clinical equipment rentals like ECG, centrifuges, and freezers for global studies? Or are you looking for tablets or mobile phones solutions for your clinical applications? Get in touch!

How Clinichain helps with clinical eHealth devices for your global study

We provide a rental solution for eHealth devices including configuration, validation and global shipments to achieve quality results for clinical studies.

5 steps to provide suitable eHealth solution:

 

1Determine the right eHealth device and solution for your clinical study

Based on your study requirements, we source and rent out every type of wearable device you need for your study. We provide tablets and mobile phones to perform your clinical application, including local Wi-Fi hotspots or 4G possibilities on a global scale.

 

2Configuration and validation of your clinical eHealth device

To simplify the process, we pre-program or offer (system) configuration to make sure the tablet is ready to use at the clinical site for EDC purposes.

 

3Provide global shipments to site locations

To prevent delays, we ensure your clinical eHealth devices will arrive timely, as we work with third party logistics providers and utilize our equipment network to source and provide locally within challenging countries.

 

4Maintenance, replacement and project management

To make sure we can replace in timely fashion during a study, we built extra inventory for your specific study to ensure fast replacement service. For your entire study, you will have one single point of contact who will be able to answer all of your clinical equipment related questions.

 

5Data wipe out and disposal service

Throughout our SOP’s for Good Computing Practices, we will follow your study quality restrictions. Our Inhouse data experts wipe out all data which is left behind after receiving equipment. For this service we can provide you with a certificate with listed equipment and serial number(s).

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Business development intern

Business development / marketing internship:

We are looking for an great talented business development intern!

Clinichain is a rapidly growing entrepreneurial company focused on clinical studies within the pharmaceutical industry. We believe in an open way of communication and give people freedom and responsibility to act like an entrepreneur within an organization. Within our core business we provide clinical equipment, kits and support logistic needs for global clinical studies.
How does this internship look like? We would like you to get introduced with the entire sales cycle of business development.

This contains 3 areas where we hope to inspire you:

1. Marketing

  • Market research to focus on new markets and new services within the same market of the pharma industry.
  • Help generate new content and think about new marketing ideas to come in the picture with our potential clients
  • Think about a strategy in using the right channels and tools to reach out to our target group

2. Sales cycle

  • Learn skills of consultative selling method by generating business yourself and get in the picture with the right target group. Assist and perform with telephone conference and decision making meetings
  • Source for new prospects and decision makers
  • Analyze and manage the sales funnel.

3. Learning more about medical equipment service and clinical study processes.

  • Built a network within the Pharma industry
  • Engage knowledge about clinical studies and medical equipment to become an expert within this industry

Who are we searching for:

  • Great personality and driven person who is willing to learn everything about Business development within the pharma industry
  • English fluently (preferably, native speaking)

What do we offer?

  • A great flexible workspace
  • chance for a fixed job after the intern period
  • market conform intern salary, based on level of experience-2-5 days flexible working days. (period is minimum 2 months)

Contact us for more info.