Are your clinical trials delayed due to complicated validation processes?
Accelerate clinical trial results by achieving validation compliance with GO!FIVE® — up to 6x faster
Good Clinical Practices (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.
When using digital management of clinical trial data and/or electronic systems for managing this data, it is essential to ensure and document that these systems meet the requirements for integrity, accuracy, reliability, and consistent performance as expected. This is the role of computerized systems validation (CSV).
Studies must be strictly monitored to ensure compliance with regulations as well as to guarantee the safety of the patients involved.
Typically, pharmaceutical, cosmetic, medical device, or herbal medicine industries sponsor clinical studies.
These industries are generally the holders of the rights to those products and are responsible for designing and publishing the information obtained from the study.
It is possible to transfer any or all duties and functions related to the trial to Contract Research Organizations (CROs). However, despite the transfer, the ultimate responsibility for the quality and integrity of the trial data always lies with the sponsor.
CROs can operate from the early stages of research and development (R&D) to preclinical trials, clinical trials, and even post-market surveillance.
Imagine that without validation, there is a regulatory risk, and when absent or inadequate, it can delay the registration and marketing of products.
The validation professional in the laboratory/hospital/clinical research center must base their approach to validation on the intended use of the system and the potential risk of affecting participant health protection and trial reliability.
Therefore, having a tool that uses agile methods and includes various validations/qualifications in the database, speeding up documentation by up to 6x, can be the solution.
And how does the regulated company ensure that CROs meet regulatory requirements?
Through vendor qualification!
The designated professional from the industry to monitor the CRO's trial outcomes can carry out vendor qualification to verify their compliance with regulations. Evaluations can be based on available information, audits based on questionnaires, and on-site or online audits of the supplier.
It is estimated that small and medium-sized CROs represent 44% of the clinical research market, highlighting their relevance in the current market.
The main challenges for small and medium-sized companies include:
- Lack of qualified workforce in validation.
- Training professionals takes time.
- Validation can delay product registration and production.
- Document organization.
- Adapting layout and configuring documents.
Note: Incorrect indexing of test evidence can lead to non-compliance.
How can we increase productivity, reduce costs, and optimize validation time if hiring more people is not the solution?
As mentioned above, validation is a mandatory requirement, and small and medium-sized CROs do not always have experienced teams in the validation process.
Additionally, in the dynamic field of biotechnology, flexibility is crucial.
When working with paper-based validations, the team will face a bureaucratic process that can hinder innovation and become a bottleneck, even for acquiring new projects/clients.
To ensure business success and continuity, CROs can rely on GO!FIVE®, a digital validation software with integrated solutions. It simplifies submission processes and preparation for audits while speeding up validation studies.
The GO!FIVE® system was designed to include standard validation structures required before the start of clinical studies, including:
- Guidelines: ICH E6, ICH E2A (clinical safety data management), E3 (clinical study reporting), ICH E7 (geriatric populations), E8 (general considerations for clinical trials), ICH E9 (statistical principles), and ICH E11 R1 (pediatric populations), FDA 21 CFR Part 11 ANNEX 11 EMA.
- OHRP (Office for Human Research Protections) Policy and Guidance Index: 45 CFR 46 Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; Subpart B (additional protections for pregnant women, human fetuses, and neonates); Subpart C (additional protections for prisoners); and Subpart D (additional protections for children) are regulations that complement Subpart A, providing additional protections for vulnerable populations.
- FDA Clinical Trials Guidance Documents; Information for Clinical Investigators-Drugs (CDER), Information for Clinical Investigators-Devices (CDRH), Information for Clinical Investigators-Biologic (CBER).
What does the market think of us?
Everyone was always very helpful and provided solutions for the smooth running of the project.
Excellent support and response time, along with expertise in processes that help us maintain the quality of the service provided to our clients.
Overall, the FIVE team showed great commitment to the project and was a valuable partner in solving the challenges encountered. It has been a pleasure working with you during this time.
FIVE has a team highly committed to project deadlines and quality.
The validation service provided by the contracted company was a learning experience for us at Ajinomoto, exceeding our expectations in every aspect and contributing to our learning. The team demonstrated technical knowledge, commitment, and efficiency throughout the entire process. We are pleased with the results achieved and recommend your services without hesitation.
A company highly committed to delivering a validation package with a high level of excellence, sometimes even exceeding our validation vision, using technological resources as support to expedite deliveries promptly.
I deeply appreciate the entire team for the quality in delivering the entire validation package and for meeting the deadlines of our challenging schedule. Congratulations on the work and tools used. It was a pleasure working with you!
Excellent work and validation completed in a short time.
I appreciate the support and dedication of FIVE Validation to help us successfully complete this project!
I want to use this opportunity to thank FIVE and to praise your work on Belupo validation project so far. I understand that FIVE validation is a good partner for Belupo and that the team is really quick and fast in providing the service. Special thanks to the validation analyst with who we have a great collaboration and communication.
It was the first work experience using the GO!FIVE® tool. I considered it excellent mainly in the aspect of agility and data integrity. Great tool, mainly when teams are allocated to physically separate plants.
We had positive feedback from many people who attended the webinar. The subject was specific, according to our reality. They dominate the subject a lot! Very good!
A company committed and always meeting all the deadlines proposed for the project.
FIVE is a serious company and committed to the quality of medicines through the systems validation services provided to the pharmaceutical industries. Refined expertise and a high degree of knowledge in validation.
There is a great ease of doing business and working with FIVE, due to the high level of understanding and training of their employees.
The FIVE team, besides their great knowledge, is always very committed to the tasks, facilitating the progress of the project.
I am very grateful to the "FIVE" team for their excellent leadership with the project. FIVE's success is due to the commitment and efficiency of its work. Thank you very much for your help in our many questions and defining courses for actions.
The FIVE team gave all the necessary support so that the validation happened as planned and within the agreed deadlines. It was an excellent team work.
Once again I would like to thank FIVE for their understanding and professionalism, especially our project colleagues who were extremely assertive and dedicated, contributing a lot to the success of this project!
I thank the entire FIVE team for their attention and commitment. The analysts and supervisors are wonderful professionals.
I would like to congratulate the FIVE team for being extremely professional.
This project ran effortlessly and the FIVE team was always available to help. This type of project was, by its idiosyncracies and complexity, a real drain of time, so a realistic, well-managed and well-trained team, along with the programming are just some of the reasons for our success. The GO!FIVE® platform helped to give speed and confidence.
The realization of the project by the FIVE team was of extreme dedication and cooperation. On behalf of Torrent, I would like to thank all the specialists for their professionalism, and being efficient! The GO!FIVE® system is intuitive and was of great value. We are very happy to have finished this journey with FIVE, and hope that soon we will be together for other successful projects in the future.
Congratulations, very helpful staff.
It was a very valuable training for me, especially in the automation part, which I didn't know much about.
Excellent training, very didactic and interactive. Being conducted onsite facilitated the interaction and learning a lot.
The FIVE employees' expertise, who were involved in the project, especially the system to be validated and the validation concepts, helped BIOMM to carry out the project effortlessly.
It was a challenging and very difficult project for the company, Five's support and critical vision were essential for this project's success.
The entire project was well-organized in all its facets, meeting all of Ceva's needs. The conducting of the validation activities occurred pro-actively, objectively and quickly, both in the aspects of interpersonal relationships and the technical discussions to resolve problems encountered during the project. The whole process of documentation was logical. Review and execution with GO!FIVE® was very easy to do.
This project was my first experience with FIVE, and I have nothing but praise for them. I was given the project in the middle of the process and the people at FIVE gave me all the support that I needed to understand the stage where our group was at, and were very patient in showing me how to execute the tasks in the application. I thank FIVE for all their commitment and dedication. Thank you so much!
Very satisfied.
Simply efficient
I think the system is nice and easy to use from the point of view of those who go into it to approve documentations.
Very productive contents.
Very valuable content.
The process change of document elaboration, items discussion and tests execution was more efficient, because the strategy was to follow the matrix lines, speeding up the validation process and activities management, while working on improvements in parallel. The work of the validation professionals was exceptional.
"Project carried out excellently, always in touch and taking into consideration the scores given by Hypofarma."
"Just grateful to the FIVE team for their support and dedication to our project."
"Extremely organized work, what was agreed upon was provided."
"We carried out a high-impact project in partnership with FIVE, which, through the use of the GO!FIVE® software in the execution of qualification and validation tests, provided us with a 20% reduction in workload allocated to these activities, as well as saving one month of work from various teams while meeting internal quality standards."
"Great professionals, have a broad validation knowledge, produce excellent documents, have initiative and take the right decisions when needed, and help the rest of the team above what should be expected from them. Happy to work with FIVE!"
The whole team is very friendly and helpful. They also have great technical expertise
A team that assisted us was very helpful
Great commitment from the team in delivering the project, along with excellent interpersonal relationships
The use of GO!FIVE®, as well as the libraries provided in the system, has resulted in a significant improvement in the efficiency of generating subject-specific documents and simplification of review and approval routines. Our expectation is to manage all validations in the software, as well as maintenance and periodic reviews in the future
Great presentation! Great overview!
Really interesting software!
An easily accessible system for both approving evidence and navigating
We were always very well-handled by FIVE consultants. They were very helpful in assisting us with our project and questions.
In general, this project was very good, FIVE's team provided all necessary assistance during the project. They clarified all questions and provided several alternatives during the discussion, helping us to solve our problems.
I emphasize the dedication of the professionals involved in the project, including their professionalism and willingness to answer questions and propose solutions.
Great job.
Thanks for your partnership.
We have FIVE as a great partner and consultant. I strongly say that FIVE professionals brought a new culture of information security and data integrity to Fagron. Thank you very much.
Very didactic and attentive tutor. Congratulations.
We had all meetings attended and proposals delivered on time.
The work was carried out in an agile and assertive manner. We always had the support of FIVE during the project.
Excellent job!
Seriousness and competence.
Very satisfactory, with compliance with the deadlines and specialized team.
Working with FIVE on this project was an amazing experience!
Efficient and assertive, excellent! The portal of GO!FIVE® is very good, congratulations! Great validation analysts and we must congratulate the management.
We had an urgent project with a short deadline and the FIVE team met our needs and delivered all the requirements on time with the desired quality. Thanks for your partnership. Thank you very much!
FIVE's team is to be congratulated for the guidance and support with our computerized system validation project, the use of the GO!FIVE® platform also helped a lot in the success of this project.
We were always very well treated during the meetings and during the execution phase of the project. Those responsible demonstrated total mastery of the subject and competence. Congratulations to the team!
It was our first experience with external validation and it was great; very easy and well organized.
I would like to thank the FIVE team very much for all the care they had in this project. You were truly exceptional in meeting deadlines, attention, patience, planning, among other aspects.
Working with GO!FIVE® was a great experience; it significantly streamlined the 'bureaucratic' documentation processes, and its traceability features were very beneficial.
First-rate team! The GO!FIVE® platform is a very good tool for System Validation.
The technical knowledge of the FIVE team and FIVE's exclusive management tools enable the validation of computerized systems to be conducted safely and systematically.
I was very well attended to and had great support.
I was attended to by a great professional who explained very clearly and patiently the whole process to our team.
I chose FIVE due to the good reputation in the market and due to previous participation in trainings that were very well conducted.
The control, management, generation, and mandatory approval of documents are significant challenges during the validation process. GO!FIVE® prevented this from becoming an issue in the RBBL project due to proper management and approval of document versions. Throughout the 9 months of the project, there were no systemic bugs.
The partnership proved to be a complete success.
The remote validation with FIVE was quite a rewarding experience all together.
The GO!FIVE® platform is easy to use, documents are easily accessed.
