Clinical Strategy
The clinical questions that originate from the initial clinical evaluation feed into a more detailed clinical strategy. Parts of a clinical strategy involve selecting the patient population, device regulatory status, long-term strategies, formulating endpoints and statistical justification. This phase of strategy development includes scoping and decision making. Qserve CRO is your experienced partner, guiding you through this challenging process.
Qserve CRO will always consider the feasibility of operational plans, including budget, timelines, and marketing requirements.
A professional clinical strategy meets the following requirements:
Identification of specific regulatory requirements to be addressed
Evaluation of suitable countries to run your clinical activities
Evaluation of suitable sites / health care professionals to involve
Connecting risk management activities to your protocol
Identification of project risks
Evaluation of clinical claims and how your clinical protocol can be supportive
Verify the need to collect additional/other clinical data.
Project Planning
Based on a well-developed clinical strategy, the operational part can be initiated. Planning involves the set-up of essential documents, allocation of resources and selection of partners. Essential documents include a study protocol (CIP), informed consent form (ICF), case report forms (CRFs). Partners to be selected; include an electronic data capture (EDC) system provider, study sites and monitors. Submission to an ethics committee (EC) or independent review board (IRB) for approval is mandatory. In some cases, the competent authority needs to be notified as well. At Qserve CRO we have an internal team of experienced clinical research associates (CRAs) and clinical project managers (CPMs) to perform these tasks for you, or support your internal team where necessary.
Study Conduct
Operational excellence is in our DNA.In the phase of conducting your clinical activities the study sites will be initiated, first patients will be enrolled and clinical data is ready to be collected. Qserve CRO will help you manage this complete process from; site initiating and enrollment progress, monitoring and reporting of the trial, data management and analyses in compliance with GCP (ISO14155).
Data Analysis and Reporting
At Qserve CRO we have data managers and statisticians that will analyse the clinical data points collected and provide you the results. Developing the clinical investigation report (CIR) that captures the outcomes is the final step in completing your clinical activities.
Clinical Evaluation Report
The output of your clinical activities feeds into your clinical evaluation, closing the clinical gaps. A final clinical evaluation report based on sufficient clinical evidence completes your technical documentation. Initial market access or confirmed performance and safety of products in post-market phase, having your own clinical study data safeguards sufficient clinical data.
At Qserve CRO we are pleased to be your experienced and dedicated, clinical partner.
Post Market Activities
After initial market authorization, you have an obligation to collect relevant post market data, such as post market surveillance (PMS) and post market clinical follow-up (PMCF) data.
Post market clinical follow-up surveys are a popular and cost-effective way to gather clinical data. They cannot not only be used to gather sufficient clinical data to support transfer from CE-certification under the Medical Device Directive 93/42/EEC to CE-certification under the Medical Device Regulation 2017/745, but also have successfully been used to provide real world data (RWD) to support FDA submissions from a clinical perspective.
Qserve CRO has supported many PMCF surveys and can be your dedicated and experienced partner.
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