First Electronic Data Capture (EDC) Platform for Premarket Tobacco Product Application (PMTA) and Regulatory Submissions
Services
EDC
ResearchGuru platform was designed by highly skilled researchers including Epidemiologists and Biostatisticians. It offers a simple, robust, and powerful platform for data collection in research studies, including those related to regulatory submissions. The software allows researchers to collect both expremintal and observational data, which is crucial for comprehensive regulatory submissions. A key advantage of ResearchGuru is its streamlined approach: you provide the form or questionnaire, and ResearchGuru handles the programming and all services.
FDA 21 CFR Part 11 Compliance
ResearchGuru is designed to support FDA 21 CFR Part 11 compliance, a critical requirement for electronic records in studies submitted to the FDA, including PMTAs. This includes features such as audit trails, electronic signatures, user access controls, and data validation to ensure data integrity, traceability, and security. By adhering to these standards, ResearchGuru facilitates the creation of reliable and trustworthy data, which is essential for regulatory submissions and helps streamline the PMTA process.
Artificial Intelligence
Real-time Reporting
ResearchGuru provides real-time reporting capabilities for fieldwork monitoring, enabling researchers to track data collection progress and identify potential issues as they arise. This real-time visibility allows for proactive intervention and course correction, ensuring data quality and study timelines are maintained. Fieldwork monitors can access up-to-the-minute data, identify trends, and address any inconsistencies or missing information promptly, leading to more efficient data collection.
We Transform Your Vision into Creative Results
We asked 2536 researchers from different sectors about the software that they currently use to conduct their studies. Our results have shown that:
A significant majority of researchers, 81%, express dissatisfaction with their current EDC. Common complaints include the prohibitive cost of EDC software licenses, coupled with a failure to deliver on promised services and features. Furthermore, researchers often find themselves forced to utilize multiple software platforms to meet all their research needs, highlighting a gap in functionality within existing solutions. ResearchGuru addresses these challenges by offering a cost-effective, comprehensive platform that eliminates the need for multiple software subscriptions and provides the necessary tools and support for efficient and successful research.
Nearly half of all researchers, 47%, find the training process to run an EDC complex and time-consuming, often compounded by inadequate customer support. Furthermore, a majority of data mangers report that existing software lacks essential features, forcing them to constantly switch between different platforms and disrupting their workflow.
ResearchGuru’s efficient process can be particularly beneficial for PMTA submissions, where accurate and well-managed data is essential for regulatory success.
FEATURES
Advanced Features
All in Unique Platform
DATA
COLLECTION
- Log changes – record any changes
- Audit report
- Electronic signatures
- Run online and/or offline
- Support an unlimited number of participants and questions
- Support more than 80 different languages in a study
- Accept 28 types of questions (e.g. multi-choice, single-choice, drag and drop, ranking, open box, put image/video, radio question, date/time, slider and etc.)
- Define advanced conditions (e.g. Randomization, Skip Logic, Branching, Piping and Micro-tailoring and mathematical calculations)
- Record/capture geo-location, photo and video
- Customise font, logo and colours of form or survey
- Ability to upload file (i.e. image, text or video)
- Responsive system; works very well on mobile, tablet or desktop
- Sending of invitations, reminders by email
- Embed the EDC or survey on your website without any further installation
- Export raw data file in Excel, CSV, Stata or R (data file) formats
- Automatically take a backup from all studies on daily bases
- End to end encryption and store data on dedicated servers
Real-time Dashboard
- Ready to be used as soon as data collection starts
- Update/refresh the report every 2 minutes
- Insert 6 types of charts including Time series, Combo, Pie, Bar, Area and Linear charts
- Insert geo-map and pivot tables
- Define filters on the report (e.g. time frame, site, location or any other variable)
- Download the report in PDF or CSV format
- Share the report with colleagues
- Customize font, logo and colours of the report
- Import and combine raw data from external sources (e.g. Cloud SQL or Excel)
- Embed the report on your website without any further installation
Ad-hoc Services
- Data analyses, modelling data to understand risk, benefit and effectiveness of treatments
- Data management and cleansing
- Descriptive: frequencies, mean, SD, tables and etc.
- Analytical: modelling data (Logistic, Linear, Cox or Poisson regressions)
CONDITIONAL ALERT
NOTIFICATION
- Customize the conditions to detect anomalies or Adverse Events or any problematic situation (e.g. allergic reaction)
- Triggers instantly (less than few seconds) once the system detects them
- Send email(s) instantly to the researcher team or sponsor
Save Money
- No hidden fees, we only charge you for usage of software
- No need to hire employees or outsource to companies for programming
- There is not cost installation
- Do not require training to use
Save Time
- You just need to send the form or questionnaire to us and we do the programming in less than one day
- Instant access to the results and reports
- No need to spend time for training or installing any extra software or your computer or server
SOLUTIONS
ResearchGuru supports the capture and management of data for actual use or clinical studies which are particularly relevant for PMTA submissions. ResearchGuru also facilitates accurate subjects screening to ensure study objectives are met.
ResearchGuru offers comprehensive solutions for a range of observational studies such as post-market or cross-sectional.
Market research involves collecting, analyzing, and interpreting data about flavours, market, specifically regarding a particular nicotine product. This research can encompass various aspects, including:
- Market penetration and growth trends.
- Factors influencing consumer flavour choice and purchase decisions.
- Market share distribution across different product categories, consumer segments, and retail channels.
- Consumer awareness and adoption of new products or marketing campaigns.
- Effectiveness of marketing messages.
- Brand perception and image.
ABout US
Our research consulting services are led by experienced epidemiologists who bring a deep understanding of study design, data analysis, and public health principles to every project. Their expertise allows us to provide comprehensive support for a wide range of research needs, from developing robust study protocols and managing data collection to conducting advanced statistical analyses and interpreting findings. This epidemiological background ensures that our clients receive methodologically sound and scientifically rigorous research, leading to reliable and actionable results.
Christian Erikson
Director
Christian studied Epidemiology and has experience conducting primary and secondary research studies in healthcare, academic and commercial sectors.
FAQs
ResearchGuru encrypts data in transit, at rest, and on all backups.
Here’s how: Access to the ResearchGuru application is available only through secure HTTPS. Data in transit is encrypted when customers choose to use HTTPS protocols for their account. ResearchGuru utilises TLS for its secure communication protocol and is currently at the most recent patch level.
We don’t sell or share your data. ResearchGuru delivers information to you that belongs to you, not us.
Select operate to the highest standards of data security and confidentiality. We have a standard Non-Disclosure Agreement (NDA) that we can send to you. Data access is strictly controlled and our IT systems are fully secured against external intrusion.
Customer is responsible for all actions with respect to personally identifiable information of persons that respond to customer’s surveys or to whom customer sends surveys. Title to and ownership of all intellectual property rights of the Response Data shall remain exclusively with customer.
The parties agree that all disclosure and use of survey information, responses thereto and Response Data (defined below) will comply with the terms and conditions and privacy policies under which it was collected and all applicable laws, statutes, rules or regulations relating to such Response Data and the persons from whom it is collected. “Response Data” means data obtained from persons responding to and/or having received surveys from Customer. Customer further agrees and warrants that its collection and use of Response Data from those persons comports with its stated privacy policies and comports with all applicable state and local laws.
We strongly recommend you do. Custom themes enable you to customise the look and feel of your dashboard to reflect your brand.
No. If you don’t have wi-fi available we can supply 4G tablets with a SIM card which will connect to a local network provider much like your mobile phone.
Yes, please contact christian.erikson@ResearchGuru.co.uk.
We do! ResearchGuru supplies the whole system including software, hardware and stands.
No! Our service is tailored to suite your individual business and that includes completely unlimited participant and question counts.
We get back up all our systems once every day and keep it for one year.
Your business and your customers are our passion. Technology is our speciality.
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