R.S NESS offers a variety of Pharma and Medical Device development services including Clinical trial management, Clinical monitoring, Data management, Biostatistics, Medical and Safety monitoring and Medical writing.
Accumulated vast experience in a wide variety of therapeutic areas in both the medical device and pharmaceutical industries.
Clinical Trial Project Management
- A professional and effective project manager is crucial to the success of your clinical trial. Our experts support every phase of the clinical trial process with detailed and proactive project management
- The project manager maintains an overview of the trial, acting as the central point-of-contact for the Contract Research Organization (CRO), investigator, onsite medical teams, vendors and client interactions. As well as coordinating site-management and investigator payments
- The project manager ensures the study stays within timeline and budget requirements.
- A successful and on-target clinical trial must be supported by an extensive research plan and result in documentation that is both coherent and presents clinical data to the highest ethical and scientific standards
- We are dedicated to delivering medical documentation that is free from inaccuracies
- We can provide clinical study documents which are all intensely assessed from a statistical, scientific, quality control and editorial standpoint such as Study protocol, ICF, IFU, IB, Clinical Study Report (CSR), Clinical study Evaluation (CER), etc…
Clinical Monitoring & Site Management
RS-NESS clinical team ensure the highest quality review of data and effective interaction with study sites while conduct on-site monitoring visits throughout the study.
- The Case Report Form (CRF), the tool at the heart of every clinical trial, can require expensive re-work and could seriously compromise the validity of the trial’s data
- We can design case reports that conform to the strictest of regulatory guidelines and lay the groundwork for a successful trial
Clinical Trial Design
- Adaptive trial designs offer significant benefits for Biopharmaceutical and Medical Device companies looking to reduce costs and streamline the drug/device development process, increasing efficiency and success rates for their clinical programs.
- Adaptive trials use accumulating trial data with a prospective design to determine how to change aspects of a study, while maintaining study validity and integrity.
- Our consulting expertise combine clinical understanding with regulatory requirements and expectations to develop the most effective clinical trial for clearance or approval and market adoption
Clinical Regulatory Affairs
- Clinical Regulatory Affairs plays a crucial role in the pharmaceutical and Medical Device industry and is involved in all stages of product development and also after product approval and marketing.
- Our clinical staff has an excellent track record in submitting meticulous Ministry of Health, EC and CA regulatory submissions.
- Establish close associations with the relevant local health authorities, as well as deep familiarity with GCP guidelines, FDA and EU regulations and sponsor's SOPs.
- Medical monitoring is an essential component of the clinical research process
- We have Medical monitors who provide medical expertise and oversight for the entire clinical trial, from initial study design through final study close-out
- The integrity of clinical data is of paramount importance to a successful project. RS-NESS ensures this integrity by strict adherence to established operating and review procedures throughout every stage of a project.
- RS-NESS works closely with clients to determine specific clinical technology requirements and then customizes software implementation to meet each client's unique clinical data storage and processing needs