Our Key Strengths
- Initiating, managing national /
multi-national complex clinical trials
- Bench to Bedside
- Project Management for complex
- Site Management and Monitoring
Ozmosis’ services can be customized to the specific requirements of each client.
We incorporate drug development and clinical trials management expertise, quality service, and communication into the clinical trial process
We develop clinically relevant research projects designed to match the objective of the client. We have experience bringing study concepts to development.
We can recommend innovative strategies for drug development studies by offering scientific, medical, and regulatory advice on how best to develop an investigational agent.
Project management in research is critical and ensures trials are completed on time and on budget. We focus on careful planning and review of each trial. We prepare a project in collaboration with the sponsors to open trials as quickly as possible.
We believe it is important for sites to have limited points of contact for a study when working with a clinical trials management company. We assign a study to one of our clinical trial specialists and they serve as the primary contact person for the duration of the study.
Our clinical trial specialists take responsibility for project and study management, vendor management, and liaising with sites.
We partner with our customers to ensure successful project execution, offering custom-tailored support based on their specific needs. The clinical trials specialists at Ozmosis Research Inc. oversee and manage clinical studies from study start-up through to database lock.
Our relationships with clinical investigators as well as with sites and centres of academic excellence are well established and worldwide, contributing to our large pool of potential Investigators. This leads to prompt identification of qualified sites.
Feasibility assessments, pre-study visits, and verification of ongoing requirements are at the core of our site selection process.
We are experienced in organizing many types of investigator meetings and staff training sessions, from teleconferences to large well-coordinated meetings.
Ozmosis works with experienced clinical trials lawyers familiar with the clinical trial contract landscape.
We manage the monitoring and reporting of the quality, safety, and efficacy of our Phase I, II and III clinical trials. We ensure compliance with regulatory requirements on safety reporting.
We have extensive knowledge regarding North American regulations and will ensure the study maintains compliance with these regulations, as applicable.
The following are a selection of services we can provide:
- Clinical Trial Applications
- Regulatory reporting of SAEs
- Continuous correspondence with regulatory authorities
- Regulatory tracking, collection, review, and filing
- Maintenance of the trial master file
- Audit Preparation
Ozmosis offers medical monitoring services.
Ozmosis is an accredited Medidata Rave EDC partner.
We develop protocol-specific eCRFs and eCRF guidelines based on many years of oncology experience.
Our data management personnel work in close collaboration with our clients from study design through to analysis, ensuring that the data collected is valid, accurate and verifiable. We ensure data integrity at every study stage.
We provide the following:
- eCRF design and development
- Data collection and processing
- Database building
- Accredited builders
Ozmosis Research performs clinical trial monitoring in accordance with ICH GCP guidelines to ensure that the rights and well-being of human subjects are protected. This also guarantees that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s) and applicable regulatory requirements.
Our monitoring services include:
- Prestudy Visits
- Initiation Visits
- Regular Monitoring Visits
- Site Close-Out
- Drug Accountability
- Correlative Lab Visits
We work to ensure the service we provide to our clients is consistent, reliable and to the highest standard.
- Quality Metrics
- Process Reviews & Improvements
- Quality Control
- Document Control
- Quality Assurance (Audits)
- Clinical Trials Specialists serves as the primary contact person for study
- Clinical Trials Specialists takes responsibility for the project and oversees the project from beginning to end ensuring continuity
In a recent Ozmosis Customer Satisfaction Survey, 100% of sites and sponsors indicated it was clear who to contact at Ozmosis when they had a question or concern.
“I found that Ozmosis was able to provide a potential solution when an issue was brought up. Sometimes other CRO’s only bring up the issue and offer no solutions and wait for you to come up with a plan, but I found that Ozmosis was proactive in that respect. It shows that they took initiative to look into finding a solution and therefore it makes me feel like they really do care how the trial goes.”
“I have been working in clinical trials for 11 years and found Ozmosis staff to be the most professional, helpful, informed staff I have ever worked with. I hope I can do a future study with them!”