Emmes India
Message from Archana Sarda, Emmes India President
In 2006, Emmes opened the doors to our office in Bangalore with a passion and commitment to address important health initiatives in India. This expansion greatly enhanced our ability to serve clients in India and a variety of other geographic locations with high quality clinical research services supporting Phase I-IV studies. We are now a global company with a history of service in over 60 countries.
“The thing that sticks out about Emmes India is their ability to provide customized solutions to meet trials needs, like they did in our trial by designing a real-time randomization system via IWRS. Their capability to provide round the clock help desk support, willingness to work in different time zones, and seamless coordination with different teams makes them an ideal CRO.”Sr. Medical Director, Pharmaceutical Company
Emmes means truth. With truth as a guiding principle, our highest priority is always the integrity of research. Our scientific collaborations have produced a wide range of studies across diverse disease areas, with patient populations ranging from neonates to the elderly. Through such collaborations with clinical research sites, laboratories and other organizations around the world, we appreciate the opportunity to significantly advance medicine globally. We look forward to supporting you with our Advantage eClinical software, leading biostatisticians, skilled data managers and proven track record for successfully executing some of human health’s most pivotal clinical research.
Services
We deeply understand what is at stake in each individual study; and choosing Emmes to support your clinical research provides the expertise and experience to bring your work to a scientifically sound conclusion. We are committed to using the highest ethical and quality standards; we are dedicated in truth to your success.
Project Leadership
With an unwavering commitment to collaboration, Emmes provides all necessary project leadership to organize staff teams, seamlessly work with sponsors and clinicians, and efficiently manage myriad facets of your clinical research. And when reduced start-up times are critical, you can rely upon our experience and repository of tested solutions across therapeutic areas to achieve your ambitious study timelines.
Statistical Services
Your clinical research depends on professional leadership and experience in study design, interim monitoring, selection and execution of statistical analyses, as well as interpretation and presentation of data. At Emmes, our statisticians offer decades of experience analyzing dataacross a wide range of study designs, patient populations and therapeutic areas. We also offer the following:
- Protocol design
- Analytics and reporting
- Independent data and safety monitoring board services
- CDISC implementation and data standardization services
- Training and instruction for internal/external staff
- Publications in leading international journals
- Ongoing assessment of study participants’ safety, data quality and site performance
Data Management & Site Monitoring
We value the opportunity to provide data management and monitoring support for your clinical trials. Our team is proud of its proven expertise in development and implementation of sophisticated systems and processes used in all phases of organization, collection, management, interpretation and presentation of data for studies. Specifically, we are here to support you with:
- Collaboration in study design and analytics
- CRF development and database design
- Data management documents preparation
- Data quality review
- Protocol and regulatory compliance
Since its inception in 2016, Emmes India Monitoring Group has provided monitoring support for various Phase I through Phase IV clinical studies per ICH-GCP and applicable regulatory guidelines in the therapeutic areas of Vaccines and Infectious Diseases within Asia and Africa. The team has experience working on various data collection platforms including Advantage eClinical and Medidata Rave. We help by providing:
- Site Qualification or Assessment Visits
- Site Initiation Visits
- Interim monitoring visits
- Site close-out visits
- For-cause visits
- Site and CRA Audits
- Pharmacy visits
Pharmacovigilance
Emmes offers high quality, cost effective and scalable Pharmacovigilance services meeting all regulatory compliance requirements. The team is powered by highly skilled and qualified medical professionals. Services include:
- Integrated Drug Safety Database Support (Advantage eClinical)
- Individual Case Safety Report (ICSR) Management: processing, quality review, medical review and global reporting
- Safety Management Plan (SMP) writing
- Medical Information Management including help desk support
- Signal Detection and Evaluation
- Pharmacovigilance Training and Consultancy
- MedDRA and WHO Drug Coding
- Regulatory submissions