Data Management in Clinical Trials

Data storage management has always been a chief concern in all the researches and trials as they get into process. Efficient management and strategic planning of recording data is the major area which CTM (Clinical Trial Management) team focuses the most.

Time and again Data standards are defined and categorized by the industry and global authorities. Whereby, the quick and steady adoption to these pertaining and ever-changing Compliances remains the prime motive in the entire clinical and pharmaceutical industry. The standards are set and modified repeatedly to ensure that evolving and innovative technology in the Clinical Research field stands in lines with the lines set by Regulatory Authorities.

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Regulatory Affairs Services

A new drug has to undergo hard core clinical trials on human beings before it is launched for marketing. The studies on humans have always been a matter of high concern when it comes to ethical issues. To overcome and keep check on such controversies, the government has set certain standards which have to be fulfilled before proceeding towards the conduct of clinical trials.

The regulatory department ensures that the clinical trials conducted must be in compliance with the regulatory standards and guidelines (like GCP-ICH, GMP, GLP, FDA etc). The regulatory Affairs department is a link between the company/ sponsor and the government. It scrutinizes every aspect related to regulations of clinical trial during drug approval. Drug approval by the regulatory authorities is necessary prior to market launch of the product.

CRO-India helps in consultancy regarding regulatory affairs. Having rapport with the authorities, CRO-India has in-depth knowledge of all concerned regulatory affairs related to steps for drug approval. The services provided by CRO-India for Regulatory Affairs include:

Clinical Research Regulatory Affairs
Pharmaceutical Regulatory Affairs

Clinical Research Services

CRO-India works with its client since the very initial stages up to the final projection of drug in the market. The drugs we see in market are not easy to develop. They have to undergo different researches and trials before entering the market for public medication. Clinical Research can be done for entirely new drug or for existing drug refinement (Phase IV). CRO-India deals with all the aspects of Clinical Research culminating Trial management, Regulatory affairs, logistics and Quality Compliances etc.

CRO-India complies with all the QC standards in accordance with Global Standards (like FDA, GCP-ICH etc) for conducting Clinical Researches and other services. Besides hard core Clinical Researches, our complimentary service includes medical writing, online training, facility of electronic data capturing, database design, Quality assurance etc

Services offered by CRO-India

• Regulatory Affairs Services.
• Software for Clinical Research
• Clinical Trial Management.

CRO India

We have successfully conducted research work for all phases of clinical trials. Apart from it we have been effectively providing others services such as medical writing, project management of clinical trials, regulatory affairs consultancy and many more with perfection, every time, and dot on time!

CRO with difference – Our Approach

Identifying the Client’s Focus Area

Study & behavior Analysis of Clinical Research

Volunteers and Site Inventory Management

Designing the Strategy keeping the Core Objectives of research in mind

Detailing of elements which are Critical to Quality (CTQ’s)

CRO provides end-to-end Service for conducting Clinical Researches. The supplementary feature with CRO is its technology merging. We provide services and management of Clinical Trials where clinical, pharmaceutical and technology strategies converge.