Advancement in the prevention, medication, and treatment of healthcare problems has only been possible because of the good clinical practices which are being undertaken by clinical research organizations. Prior GCP guidelines were set by International Conference on Harmonization (ICH), almost every jurisdiction was adhering to different guidelines while conducting the clinical trials. Conducting clinical trials globally has become more uniform with the introduction of ICH GCP (Good Clinical Practices).
What is GCP?
Good clinical practice (GCP) is a precise and scientific quality standard for scheming, conducting and recording clinical trials. Each of these processes requires human participation. Agreement with the GCP guidelines while conducting clinical trials commits to the public that the morality, integrity, and well-being of participants in the trials are preserved.
How MSB Docs CRA Scan App comes into use?
Manual preparation of clinical trial documents while planning, conducting, and recording clinical trials requires a lot of effort and time by Clinical Research Associates. This diverts their focus on putting good clinical practices into use.
The process starts by collecting the documents from the site, preparing the documents, and finally sending the documents to trial master files for further investigations. The entire process takes approximately 10-15 minutes per document, resulting in increased complexity and a huge decline in ROI.
Here, MSB Docs CRA Scan App comes into use by amazingly digitizing the process. CRA application by MSB Docs converts the mobile device into a portable scanner to serve its purpose well. CRAs can:
- Choose Specific Workflows.
- Scan The Documents And Make The Required Adjustments.
- Add The Metadata Like Site Number, Document Level, And Document Type.
- Submit And Store Documents On The Cloud Server As Well As To The ETMF.
MSB Docs’ CRA application not only saves CRAs ample time but also enable them to harness the power and efficiency of digitization and the myriad of benefits of technology.
Challenges CROs face while meeting GCP guidelines & How the CRA scan app becomes a savior.
Clinical research organizations treat their standing appropriately in light of the fact that it brings them sponsors as well as income. A trustworthy CRO adheres to the three fundamental standards: it keeps to the spending plan, complies with time constraints, and conveys quality administrations. For adhering to these standards, CROs have to deal with the following challenges and the MSB Docs CRA scan app offers solutions to each one of them.
|CROs need to satisfy quality assurance and quality control necessities as their standing and consumer loyalty rely upon their capacity to get their products endorsed by regulatory organizations.||MSB Docs CRA application is designed with strict standards, legal enforceability, and thorough compliance with GDP, GCP, 21 CFR Part 11, HIPAA, etc. across the globe. Keeping up with the requirements becomes easier for CROs while using CRA App.|
|Defining materials and methods to be used in the study, obtaining data, and performing tests, all these processes need proper documentation along with appropriate management in archives and online databases. Collecting and maintaining data not only requires a lot of human and physical resources but high level of security and specific order as well.||CRA app converts the mobile device into a scanner and lets clinical research associates scan all the documents, send using a specific workflow, or store them on a cloud repository as well as on eTMF. This works even in areas with weak internet connections. All the documents remain in the application and sync once the connection is restored.|
|With numerous cases of security breaches, CROs are at great risk of data leaks and impaired R&D activities. This greatly affects the reliability of the company.||To ensure the highest level of security, MSB Docs hensures industry-wide data confidentiality with application-level AES 256-bit encryption, SSL, SSO/SAML authentication, and Oauth authentication. Anti-tampering controls protect the integrity of CROs documents and multi-factor verification secures the signing events.|
|CROs need to deliver maximum productivity and profit. To accomplish this, all their internal business teams including the IT team, administrative, finances, HR, and other staff requires smart management and collaboration.||Once the documents are scanned using the CRA scan app, multiple users can collaborate and make edits, review, and sign on a single document using the MSB Docs TeamRoom feature.|
Impacts of CRA Scan App
Some of the tremendous impacts of the CRA scan app recorded to date are:
- CRAs save a tremendous amount of time on-site, which is now being utilized for other tasks and operations.
- No more messing around the scanner or fussing around to get the things to the right repository.
- Data is encrypted and is not made accessible to external users. Thus, saving it from being tampered.
- A fair amount of big data security capture is leveraged by ICON as data stays on the device only for the required time or if the device is offline. Finally, it goes to the cloud server.
- Easy configuration options for metadata allow to serve every client according to their requirements.
ICON Plc. – one of the leading clinical research organizations chose the MSB Docs CRA scan application.
“The processes that usually took 13 minutes now takes only 3 minutes to finish using MBS Docs CRA Scan App” – Quoted By ICON
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Clinical research is critical in ensuring the safety and efficiency of medication and other healthcare practices intended to be used on human beings. MSB Docs CRA Scan app open ways to conduct clinical trials more efficiently by considering Good Clinical Practices (GCP). It accelerates the process of discovering drugs, hazard factors, aftereffects of treatment or general wellbeing mediations, trends and patterns of care, and medical services costs.