Agatha Clinical SOP software – Manage clinical research SOP documents and trai
Clinical SOP management software for clinical research
A ready-to-use solution for authoring, approving, managing, and publishing standard SOPs and tracking employee training activities.
Ensure compliance with an applications for managing clinical trial standard operating procedures
Standard Policies are at the heart of every Quality Operation
SOPs and employee training documents are critical to ensure effective operations and compliance with regulatory requirements during clinical research trials. Managing both in a single application makes it that much easier. That’s where Agatha SOP can help.
Manage SOPs and Employee Records
Agatha SOP is a cloud-based application that enables you to track employee SOP compliance and training activities that comes with a standard set of templates as well as standard review and approval processes. Starting with the standard configuration, you can then configure the application to support your requirements, according to your clinical trials.
Standardize your clinical operations with clinical SOP management software
Agatha’s SOP application provides audit records, documented changes, and electronic signatures to ensure every activity is fully documented, compliant with regulatory guidelines and ready for inspection.
Clients whose clinical research benefited from our standard operating procedures solution
Senior Director of Quality Assurance, BeyondSpring
How Agatha’s clinical trial SOP supports standard processes
Start with Clinical trial SOP templates
Create and document comprehensive policies from a set of standard SOP templates. Trigger periodic reviews automatically at preset intervals to ensure up-to-date training activities and comprehensive documentation according to your clinical research trials. Ensure the execution of clinical trial tasks according to institutional, provincial and federal guidance (or other applicable guidance).
Review and Approve SOPs
Manage and monitor processes for the creation, review, and approval of SOPs with ready-to-use, easy-to-modify workflows. Maintain prior versions of all SOPs and audit trails, documenting all changes to every SOP in case of any adverse events.
Track your employees compliance to new standard operating procedures
Track employee SOP compliance and training activities using training resources such as documents, presentations and videos. Require successful completion of quizzes to ensure new processes are understood. Ensure SOP compliance of responsible individuals at regular intervals to ensure up-to-date training
Track Paper Copies
Ensure that paper copies are managed properly with Controlled Print.
The best way to know if an Agatha Application meets your needs is to try it out. And good news – we offer a free trial.
You Get More with Agatha SOP
Custom Forms and Rendering
Leverage forms to drive processes based on metadata and use metadata to generate renditions. Ensure consistent data structures (unit title, sections headers, consistent font size)
Basic Preview and Annotations
Preview and annotate PDF and Office documents, and image.
Cross Workspace Reporting
Create views and reports across workspaces and export results to Excel for dashboard reporting.
Hosted in a highly secure, compliant cloud service that satisfies the needs of the most security-sensitive customers.
Easy Audit Preparation
Simplify audit preparation with complete SOP documents, accurate training records, and specialized views and reports for inspectors.
Advanced Integration Toolkit
Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation and sample code).
Learn more about standard operating procedures and Agatha’s clinical trial SOP
What are standard operating procedures (SOPs)?
Standard operating procedures (SOP) are a set of steps and procedures used by an organization to clearly describe the everyday functions needed for their business. Maintaining a standardized list with SOP management softwares helps businesses comply with industry standards, federal or provincial legislation. In clinical research, SOP templates must follow Good Clinical Practice guidelines, particularly in human subjects research.
The importance of SOPs in clinical trials
SOPs (Standard Operating Procedures) are documents that outline specific steps taken when conducting a clinical trial. Agatha’s Clinical trial SOP templates are based on various international standards, including the following:
- Food and Drug Administration (FDA);
- Office for Human Research Protections (OHRP);
- International Conference on Harmonization guidelines (ICH);
- Health Canada Food Safety requirements
- Good Clinical Practice guidelines;
- Tri-Council Policy Statement for the Ethical conduct of researching human Subjects;
Clinical trial SOP templates accelerate trials, increase the likelihood of success of clinical research, improve the speed of development, and reduce risk levels during clinical trials. Adherence to standardized operating procedures (SOPs) can ensure that these practices are consistently applied across all sites, thereby ensuring consistency in the conduct of clinical trials.
How to train employees on Agatha’s clinical trial SOP templates?
Once a pharmaceutical business chooses Agatha’s clinical trial SOP, the system manages the distribution to all employees who must comply with the SOP. In addition, any changes made to the SOP are communicated to all employees so that they can understand how the change affects them.
Agatha SOP allows administrators to track employee SOP compliance and to offer employees SOP training activities using documents and videos. By requiring successful completion of quizzes to ensure new processes are understood, pharmaceutical companies ensure Agatha’s SOP is well understood and implemented in the clinical trials.
What clinical research documents are standardized using Agatha’s SOP?
Agatha offers a standard set of templates to its users, which can then be adjusted according to the specific needs of a clinical trial. Some Clinical trial SOP templates offered by Agatha SOP include:
- Clinic Flow policies & procedures;
- Clinical research management plan;
- Protocol implementation;
- Source documentation;
- Essential documents;
- Office charts;
- Study visits and missed visits;
- Study medications;
- Toxicity management;
- Subject recruitment;
- Subject logs and codes;
- Transportation reimbursement;
- Ethics committee submission checklist;
- New protocol evaluation survey;
- Orientation manual;
- Quality management plan;
- Research coordinator checklist;
- Study nurse checklist;
- Monitoring visits;
- Regulatory affairs;
- Site assessment;
- Site responsibility;
- Patient and study identification numbers;
- Safety reports;
- Training record;