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The biggest challenge posed to initiate the trail quicker, constitutes of the monitoring processes that are used before the clinical study. PharmaExa Therapeutics is capable of providing regulatory services that assist with all stages of development of drug including the Phases II-IV, BE and device studies. The experience and understanding that PharmaExa Therapeutics has in regards to Indian drug control regulations and dealing with them, helps us in assisting the sponsors with procurement of regulatory approvals, better. We provide services that range from customized services to a packaged study management.

Our services include, but are not limited to:

PharmaExa, provides exceedingly reliable inputs for the intend of safety management plans that are complete study specific, with the help of a highly committed and experienced group of Safety Physicians, thereby ensuring there is a regular and accurate reporting and processing of AE’s & SAEs, with compliance to the regulatory guidelines.

The safety management services of PharmaExa include:

There are many ways to create first-rate data with an aim to support the safety and effectiveness claims of a product. The resources are required at potentially huge number of sites. The medical monitoring team at Pharma Research takes on these responsibilities, thereby helping you in finding investigator site support and monitoring that is faster and more efficient.

Every clinical trial depends highly on Monitors and the monitors at Pharma Research

• Ensure compliance of protocols

• Ensure precision and dependability of clinical data

• Apply applicable regulatory requirements, GCP and SOPs

• Protect the rights, security and health of your clinical trial subjects

• Support fast recruitment

• Oversee the advancement of your clinical trial

• Help to increase approval of clinical data by the regulatory authorities

At Pharma Research, we hold the faith that efficient leaders holding the wheels in the front seat, is highly crucial for the success of any project. And so, we make sure a group of highly experienced, skilled and trained personnel complete the project management team at Pharma Research.

The basic anxiety of the customers in relation to medical trials within a specified timeline and budget is one of the top priorities for the project managers at Acro Therapeutics, who make sure they have a detailed mitigation plan and risk management.

The basic functions include: