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ECRO, India

Elixir serves as Type-B Site Management Organization. It provides a full range of clinical development services including comprehensive Phase II & III clinical trials, regulatory submission, project and site management, clinical trial monitoring and, medical & scientific writing. Our U.S. office is located in Coral Springs, Florida.

Elixir Clinical Research Organization has a network of sites which conducts clinical trials phases II to IV for various indications. The organization has a dynamic network of medical specialists and hospitals.

It specializes in systematic advertising and providing a large database of patients to ensure an efficient patient recruitment.

The company has a well-trained and highly-experienced staff who can conduct a clinical study following all ICH-GCP guidelines and high quality documentation. For evaluating the efficacy and tolerability of pharmaceuticals, a target orientated planning and execution of multicenter trials phases II to IV are essential. Those are important milestones on the way to licensed new medications. Elixir Clinical Research Organization provides a tailored solution to serve such needs of the Sponsors/CROs.

Our team includes highly experienced Medical-Writers providing the CROs and Sponsors with all study specific documents and presentation services from one source. We support CRO and Sponsors in professional literature research, in generating Study Protocols, Informed Consent Documents, submission documents, Case Report Forms and Clinical Study Reports, and provide presentation services for publications, posters, lectures, marketing or training material.

The services offered by ECRO are:

  • Start-up Activities
  • Monitoring Services
  • Safety Management
  • Project Management
  • Regulatory Services
  • Complete Clinical Trail Execution

Our Services also include GCP Audit Services

Systematic audits are essential for the success of drug approval. They ensure that data from clinical trials are reliable and subjects' rights are protected. By identifying and solving arising problems at an early stage, audits can help you to save time, energy and costs.

Our independent Quality Assurance team offers comprehensive audit services. Our auditors assess the compliance with ICH-GCP, your protocol, Standard Operating Procedures and country-specific requirements. On the basis of the detected deficiencies our experienced auditors provide valuable recommendations that will significantly improve your study performance.

Audit Preparation and Conduct

  • Audit Plan
  • Audit Report with Grading of Observations
  • Recommendations for Improvement
  • Corrective Action Plan
  • Audit Certificate

Audits

  • Investigator Site Audits
  • System Audits
  • In-house Audits / TMF Audits
  • Vendor Audits

Audits of Study Documents

  • Protocol
  • Informed Consent Form
  • Case Report Form
  • Clinical Study Report

Professionally reviewed study documents can reduce the time for approval and therefore have a positive impact on your study milestones. Other services also include:

  • Preparation and Review of SOPs
  • Training in GCP Requirements

 

GCP Training for Investigators and Study Nurses / Study Coordinators

Recently Elixir Clinical Research Organization has started offering GCP training. The GCP training is focused on educating investigators, clinical coordinators and nurse practioner about their role, tasks and responsibilities according to ICH-GCP guideline and legal requirements. The training program covers all topics of relevance for a high-quality conduct of clinical trials. The training course is given on spot or during the investigator meetings to the clinical study team upon request. At the end of our GCP training you will receive a certificate of attendance which can be submitted to the responsible Ethics Committees as evidence of your (refreshed) qualification as clinical trial investigator.