Services
Ipsum provides a range of services for pharmaceutical and medical device development. Our practice is broken down into three main areas.
Site Management Services
IPSUM is a leading SMO with local expertise covering patient recruitment, trial preparation, management and patient retention.
We recruit and retain more engaged patients, at fewer sites, and in less time than conventional trial sites, augmenting the quality and efficiency of our customers’ drug development pipeline. We have learned that, by engaging fully with patients, our clinical trials can be conducted more successfully and, in consequence, patient retention increases considerably. And because our clinical trial model is carefully applied throughout sites, we can offer clients consistent trials in all the country. One contract with IPSUM leads to large-scale patient recruitment with multiple sites to simplify trial management strategies.
Clinical Research Services
Our main services are:
- Feasibility Studies
- Consulting and assistance for the complete design of clinical research documents in compliance with International Good Clinical Practices (GCP’s), and Standard Operation Procedures (SOP’s)
- Project Planning
- Clinical Plan Development
- Site Identification and Assessment
- Regulatory Affairs
- Coordination of Investigational Sites
- Clinical Monitoring
- Medical Monitoring
- Quality Assurance
- Management of drug and laboratory samples
- Registration of new products / indications
Technology Services
Validated Software Development:
The U.S. Food and Drug Administration (FDA) and other international agencies require that computer software infrastructure and applications are appropriately tested for their regulated uses. Validation provides the required documented evidence through a process of planning, requirements definition, test development, test execution and final reporting. Additionally, operational procedures are reviewed to ensure ongoing compliance. Source Meridian specializes in providing full scope validation and compliance services to ensure that mission critical business systems are functional and in compliance.As a global leader specializing in providing a full scope software testing and validation services, Source Meridian helps life sciences companies ensure that key business systems are functional and in full compliance with applicable FDA and international regulations and guidelines. We understand that computer systems are a key element of a company’s risk management strategy, and aim to ensure these systems are running efficiently and accurately.
Our main services are:
Ipsum provides services for medical device companies for companion software for their devices. Ipsum has worked with device makers on firmware development, HIPPA Compliant application development, as well as connected device and mobile development.
Statistical Analysis Staff Augmentation Services:
Ipsum provides staff augmentation services for SAS and statistical reporting as part of our suite of technology services. We provide skilled SAS programmers with clinical background, in the same time zone / work day as US companies.
Our validation deliverables include:
- Master Validation Plan
- User Requirements and Specifications
- Risk Assessment
- Requirements Trace Matrix
- Test Protocols
- Execute test scripts
- Validation Summary reporting
What It IncludesSource Meridian’s software validation expertise includes enterprise software applications, software as a service (SaaS) and virtualized infrastructure solutions such as VMware. In addition to focusing on software systems, our validation process addresses training and the effectiveness of operating procedures. We also offer a maintenance program that provides a cost effective way to stay in compliance.
