Our World Class Services
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:
- Registration of products for marketing approval
- Import license of drugs
- Regulatory database compilation
- Safety reports
- Regulatory approvals for different stages of drug deve
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 PharmaExa 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 PharmaExa
- 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
Therapeutic Expertise
Reproductive Endocrinology
Neurology
Inclusive Research
We are committed to conducting clinical research that is inclusive and accessible, ensuring ethical standards and equal consideration for all participant groups, including individuals with disabilities.
Feasibility & Site Selection
The success of any clinical trial depends heavily on a methodical feasibility assessment and precise site selection. At Pharma Research, feasibility forms the foundation of our proposal development and project planning activities.
Our experienced feasibility team has worked across a wide range of therapeutic areas, maintaining direct communication with trial sites and key investigators. This structured approach enables us to identify the most suitable investigative sites for conducting clinical trials, ensuring efficiency, compliance, and high-quality outcomes.
Clinical Trial Management Expertise
Our dedicated team brings extensive experience in coordinating Phase II to Phase IV clinical trials at both national and international levels. We provide comprehensive clinical trial services, managing every stage of the study lifecycle—from feasibility assessment to final clinical study report—in line with the highest quality and regulatory standards.
With strong therapeutic expertise, excellent collaboration with site personnel, and deep understanding of local regulatory requirements, we ensure seamless trial execution. While our core focus lies in South and South-East Asia, our network of partner CROs allows us to support studies across Asia and other global regions. Our flexible resourcing model combines local expertise with operational adaptability to meet study-specific needs.
Clinical Monitoring Excellence
Clinical monitoring plays a critical role in ensuring project success. As part of our commitment to Clinical Research Excellence, we have designed the role of our monitors to extend beyond technical accuracy.
Our Clinical Research Associates (CRAs) are trained to anticipate site management challenges and proactively develop and implement effective solutions. This proactive approach is applied from the earliest stages of the study and continues throughout trial conduct, ensuring smooth operations and timely responsiveness.
All monitors are full-time, bilingual professionals, equipped with laptops and accessible via mobile and internet connectivity at all times, ensuring uninterrupted support to study sites.
Flexible & Full-Service Clinical Solutions
Whether supporting your organization during periods of high workload or delivering a full-service clinical program, our clinical trials management team offers the expertise and skilled professionals needed to ensure success.
Our Clinical Services Include
- Customized clinical services tailored to project requirements
- Study document development
- CRA management and quality control
- Clinical monitoring and site management
- Clinical Trial Management System (CTMS) support
- Investigator meeting planning and coordination
- Third-party vendor management
- Audits and audit preparation
- Training programs
- Patient recruitment and retention strategies
- Feasibility studies
- High-quality training for clinical research associates
At PharmaExa Life Sciences, 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 PharmaExa Life Sciences.
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 PharmExa Life Sciences, who make sure they have a detailed mitigation plan and risk management.
The basic functions include:
- Site Monitoring
- Study Feasibility
- Clinical Trial Supply Management
- Site and Investigator Selection
