Management of Clinical trials

Adequate Management of Clinical Trials is imperative in assuring safe subjects, quality data and a well-executed study. For each phase of clinical monitoring, Beuker Clinical Research Consultancy will provide to the client in a timely manner, a complete, detailed report after each completed clinical monitoring service.

Conducting of Phase I to Phase IV studies including

Feasibility studies/ Selection visits

BeukerCRC initiates a complete assessment of each clinical research site, capabilities of staff and evaluates the site’s ability to adhere to regulations, Good Clinical Practices (GCP’s) and the overall conduct of clinical trials.

Initiation visits

BeukerCRC provides full initiation of the clinical research site which includes but is not limited to, review of protocol, regulatory documents, Case Report Form, enrollment requirements, investigational drug and responsibilities for the conduct of the clinical trial.

Monitoring visits

To ensure quality, BeukerCRC conducts ongoing clinical monitoring throughout the conduct of the clinical trial. Activities include: informed consent review, eligibility verification, Case Report Form and source documentation review, data retrieval, ongoing maintenance and review of regulatory documents, assessment of protocol adherence and drug accountability.

Closeout visits

Upon completion of the clinical trial, BeukerCRC provides, final retrieval of all data, resolution of data clarification queries, assessment of regulatory documents, review of site regulatory obligations, investigational drug accountability and return.

Trip Report Review and Submission

Training of investigators staff

Timeline Tracking

Translation of all documents from and to all languages

Other services such as Data Management, medical writing, etc. are also offered in collaboration with our consultants.

 

Regulatory and EC Submissions

Clinical trials in Europe must be conducted in compliance with ICH, GCP, the European Clinical Trial Directive and local regulatory requirements. Our strong knowledge of national as well as global regulatory policies and experience with national regulatory authorities ensures swift and hassle free regulatory approvals. Our regulatory experts can quickly identify the potential regulatory requirements thereby maximizing the chances of success with European regulatory authorities.

Beuker CRC has the experience and knowledge to prepare your regulatory packages of essential documents and manage submissions to regulatory authorities and local Ethics Committees in a timely manner ensuring a fast study start-up from phase I till IV.

For large multi-centre studies efficient completion of this step can make all the difference between meeting the projected timelines and being left behind.

Consultant Biographies

Biographies and/or curriculum vitae are provided to potential clients once a project is bid upon. Due to respect of confidentiality of our consultants, this information is not shared on this web site. Careful attention is given to match consultants with tasks and services needed by the client. All consultants are required to undergo training in the Standard Operating Procedures of Beuker Clinical Research Consultancy to ensure high quality standards to each and every client.