KlinEra Advantage: Customized Services

KlinEra recognizes the uniqueness of each project and provides customized services to all of our clients based specifically on your individual needs.

From Clinical Research Associates (CRA's), medical monitors, and medical writers, to enrollment, local governance and site management services, we can meet any of your clinical research requirements regardless of the size of your organization.

This includes individual Phase 1, 2 or 3 studies and complete end-to-end solutions that utilize our large database of consultants enabling KlinEra to work at a capacity that is flexible and consistently meets or exceeds the requirements of any given project.

World-Class Clinical Research Capabilities

We are committed to providing timely, first-class clinical research capabilities to the pharmaceutical, biotech and medical device industries.

Utilizing our distinct advantages of a global reach combined with local knowledge, we efficiently and accurately manage, monitor, collect, validate, analyze, report and deliver high-quality clinical data.

With our highly trained project management staff, KlinEra continues to excel in clinical trials in the global market by:

  • Advocating for the sponsor in interactions with foreign governments and authorities
  • Never accepting a project without the adequate resources available to complete it successfully
  • Providing quality site management support with tools that are both user-friendly and responsive to the needs of the sites
  • Providing an efficient communications plan that meets the needs of the sponsor
  • Clearly allocating the responsibilities between the project manager and the sponsor

Worldwide Operations

KlinEra operates on an international scale lowering costs and improving the quality, efficiency, and safety of biomedical research across the United States, Europe, Southeast Asia, India and Russia.

India Operations

KlinEra’s strong presence in India and our intimate knowledge of Indian law and regulations simplify the clinical trial process for sponsors unfamiliar with this region.

Specifically, sponsors desiring to conduct trials in India will experience an exceptionally seamless transition while working with us because of our capacity to provide clinical trial sponsors with comprehensive project teams in both the United States and India.

Acting as liaison between India and the trial sponsor, KlinEra’s project managers pave the way for clinical trials in unfamiliar territories to sponsor and, thus, realize cost-effective clinical development solutions.

India has rapidly become the locale of choice in the clinical trial process.
Its clinical research organization (CRO) sector is experiencing revenues of Rs. 3.5 billion (about U.S. $75 million) and was expected to reach Rs.13 billion (about U.S. $281 million) by 2010 (McKinsey Report). India’s combination of project management skills, high-tech sophistication, and low labor costs make it an attractive destination for conducting trials.

Other advantages include:

KlinEra’s extensive and proven local insight on the economic and ethnic environment and regulatory procedures ensures a smooth execution of projects conducted in India. Beginning with the regulatory filings, data lock and all the way through final report writing, our experience managing these projects ensures data integrity and quality from start to finish.

Specialized services such as the provision of ICFs and other study-related materials in Indian languages, including their back translations, are also provided for sponsors with operations in India.

Europe, Southeast Asia and Russia Operations

KlinEra is also able to offer our clients a global solution to your clinical research needs by coordinating with our global partners and highly experienced staff based in these regions to provide clients with a comprehensive solution to completing their global clinical trials in a timely and cost effective manner.


KlinEra provides resources to companies involved with clinical trials and market approval processes to complete your team or fill a gap in an existing team.

Because we're committed to providing our clients with the highest level of quality services, we employ and contract exclusively with professionals that have extensive experience in their specialized fields of the clinical research process.

This includes teams of medical writers, medical monitors, biostatisticians, project managers, clinical research associates (CRAs), and quality assurance personnel.

Databases:

KlinEra has a comprehensive databases of clinical trial investigators in the various therapeutic areas we support to help clients create a team, or fill a gap on an existing team:

  • Cardiovascular – over 300 Investigators in our database
  • Oncology – over 200 Investigators in our database
  • Respiratory – over 100 Investigators in our database
  • Psychiatry – over 100 Investigators in our database
  • Other Therapeutic areas – over 200 Investigators in our database