Ozmosis Research Inc

Ozmosis Research Inc. services can be customized to the specific requirements of each client. We incorporate drug development and clinical trials management expertise, quality service, and open communication throughout the clinical trial process.

Ozmosis Research Inc. is committed to adhering to ICH GCP, regulatory guidelines, client specifications, and our own strict internal standards.

Our relationship with our clients is of key importance to Ozmosis Research Inc. We work collaboratively to ensure communication flows well and the trial runs efficiently.

Våre tjenester

Concept Development

We develop clinically relevant research projects designed to match the objective of the client. We have experience bringing study concepts to development within the following clinical research areas:

	Phase I
	Phase II
	Phase III
	Pharmacokinetic Studies
	Pharmacodynamic Studies

We can recommend innovative strategies for drug development studies by offering scientific, medical, and regulatory advice on how best to develop an investigational agent.

Protocol Development

Ozmosis Research Inc. has experienced medical writers who collaborate with our medical staff, statistical, and regulatory personnel in developing well-designed and practical protocols.

We bring strong regulatory and functional aspects to protocol development while ensuring patient safety remains a priority.

We implement an extensive protocol review process which ensures a well-written protocol is submitted to regulatory agencies for approval.

Our staff is qualified to develop GCP-compliant consent forms for specific protocols.

Feasibility Assessment(s) / Site Selection and Study Start Up

Our relationships with clinical investigators as well as with sites and centres of academic excellence is 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 Research Inc. will liaise with the appropriate parties in negotiating contracts and budgets.

Regulatory Services

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 regulatory documents 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
	Assistance with REB responses – ensuring sites are ready to open as expeditiously as possible
	Regulatory document tracking, collection, review and filing
	Maintenance of the study master file
	Maintenance of the investigator study files
	Audit Preparation

Project and Site Management


	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. Our goal is to have a time-efficient multi-parametric work flow rather than a sequential work flow which slows down projects. This is what we call our ‘Ozmosis Advantage’.
	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, in-house monitoring, 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 and writing of the final report.

Monitoring

Ozmosis Research Inc. 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
	Study Supply Reconciliation

Serious Adverse Event Management


	Ozmosis Research Inc. has experience managing adverse event and serious adverse event reporting.
	CRFs are reviewed and monitoring of source data is performed to ensure all events are reported appropriately.
	Ozmosis Research Inc. provides initial and ongoing staff training for reporting requirements of AE’s and SAE’s.
	Our staff physicians are qualified to provide medical monitoring of adverse events.

Data Management Services

We develop protocol-specific CRFs and CRF 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 data collected is valid, accurate and verifiable.

We ensure data integrity at every study stage.

We provide the following:

	Data entry and data clarification
	CRF design and development
	Data collection and processing
	Statistical analysis and final reporting