Sponsor & CRO

Feasibility and site selection:

AMRs assists sponsors and CROs in conducting onsite and offsite feasibility and site selection.

Site development:

AMRs helps new and developing sites and hospitals in setting up their clinical research department. We train the staff and assist and support them in becoming a competent site for executing clinical trials as per regulatory standards.

Project management: Start up to close out

With the trained staff at AMRs we assure smooth transition of the project from startup to closeout assuring compliance with all regulatory and ethical principles.

Budget handling and legal assistance:

AMRs acts as a bridge between Sponsors/CROs and site in finalizing the budget.

EC submissions and IRB support:

AMRs ensures timely submissions of EC dossier as per regulatory guidelines and EC SOP. AMRs also provides technical support to IRBs for their smooth functioning.

Quality assurance/Monitoring/Audit:

With the help of our experienced staff, AMRs assures the quality data is generated by conducting regular monitoring and evaluation of the site. AMRs also provides the necessary support and assistance to the sites at the time of audits and inspections.

Regulatory Submissions:

AMRs assists Sponsors/CROs in preparing the documents for the regulatory submissions for various indications and phases of the trial.

Medical writing:

We have trained and experienced staff to support Sponsor/CRO in medical writing which includes Protocol writing/Review, Clinical Study Report writing/review etc.

SEC meeting preparation:

AMRs holds ample experience in assisting Sponsors/CROs in SEC preparations like Executive summary preparation, Power Point preparation along with Participation and Presentation of PPT during SEC meetings.