Clinical Affair

R.S NESS Group 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.

Clinical Experience

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.

Medical Writing

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.

CRF Design

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

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

Data management

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