The CRO’s CRO
  Quality Focus
     
Next CRO operates under its own Standard Operating Procedures (SOPs) complying with the industry standards and the international regulatory guidelines such as the ones set by GCP, ICH, FDA.

Our SOPs run all the operations of the clinical trial :
  • Study design and Safety Requirements
  • Investigational Materials
  • Administration
  • Product Lifecycle Support
  • Field Operations
  • Legal and Contracts
  • Planning
  • Medical Communications
  • Audits Inspections and Quality Assurance
  • Organization and Training
  • Records, Reports and Data Management
  • Medical Administration

We maintain our SOPs on an ongoing update process. They regularly go through third-party audits. As such we have asked for an ISO 9001 certification which is currently pending.

We also comply with the CFR (Code of Federal Regulations) part 11.

With regard to the medical device area, Next CRO is implementing the ISO 14155 1&2, the highest quality standards.
Today's Footprint  
•  Medical Facilities 15
•  Patient Beds 8,000
•  Physicians 1,700
•  Patients 4 million
 
Whether it is phase II - IV clinical trials or validation trials, Next CRO is positioned to provide quality trials in a timely manner all focused on the needs of the CRO industry.

For more information contact
Mr. Vajih Khan – Director Client Services at:
                       
 
             
 
A CRO’s CRO Next CRO works under both GCP guidelines as well as ISO standards to ensure high level of trust and reliability for not only the data, but also the organization interactions. Using reliable CDMS coded with known dictionaries, data is available for easy analysis and reporting.