TrialMed Life Sciences, LLC
Ph:714-658-3039 (US); raj@trialmed.com
Is a US based CRO providing clinical trial and regulatory services to start up medical device companies.
We have clinical trial expereince in the USA, India, Taiwan, Turkey, Brazil, Singapore, EU and Mexico
Our Services: Providing services based on intelligence gathered from clinical
clinical and regulatory experience over 13 years, our priority is safety of patients and users. We ensure FDA GCP guidelines are followed, patients are recruited faster and data generated is prestine. We target all therapeutic areas.
clinical and regulatory experience over 13 years, our priority is safety of patients and users. We ensure FDA GCP guidelines are followed, patients are recruited faster and data generated is prestine. We target all therapeutic areas.
• Clinical Trial Design
• Investigator Services/Patient recruitment is faster with our "patientfast" process
• Clinical Trial Management
• Investigational Site Monitoring
• Quality Assurance Auditing
• Data Management / Statistics
• Regulatory Consulting for IDE and PMA submissions
• Medical Communications
• CRA & Sales Training
• Regulatory strategy for OEM, and medical device servicing agencies.
C L I N I C A L & R E G U L AT O R Y I N T E L L I G E N C E: http://www.trialmed.com/
In the USA: We are providing services to start-up companies who have strategically planned to pursue the US market and FDA approval of their product using U.S clinical data. We provide all
clinical and regulatory services in this regard. We can also dialog with the regulatory agencies
to consider international clinical data to bring your product early to market
clinical and regulatory services in this regard. We can also dialog with the regulatory agencies
to consider international clinical data to bring your product early to market
WE CAN DO TRIALS IN T A I W A N , I N D I A ,B R A Z I L, TURKEY & MEXICO
Applying right clinical strategy for getting your product early to market is the imminent need
with new life sciences companies design can be a time saver. Case Report Forms (CRFs) designed by experts results in efficient data collection. Pursuing clinical and protocol end points in a strategic manner. Developing customer relationship with sites. First time accurate monitoring. Adhering to protocol and FDA guidelines. Respecting patient safety and confidentiality. Focus on inventory accountability and core lab evaluations. Establish data safety monitoring board. Training data management with protocol Our expertise covers a full range
of services related to Phase I,Phase II, post marketing medical device trials, 510K, PMA and
HDE (humanitarian device exemption) and similar clinical studies for US and international
regulatory submission.
Applying right clinical strategy for getting your product early to market is the imminent need
with new life sciences companies design can be a time saver. Case Report Forms (CRFs) designed by experts results in efficient data collection. Pursuing clinical and protocol end points in a strategic manner. Developing customer relationship with sites. First time accurate monitoring. Adhering to protocol and FDA guidelines. Respecting patient safety and confidentiality. Focus on inventory accountability and core lab evaluations. Establish data safety monitoring board. Training data management with protocol Our expertise covers a full range
of services related to Phase I,Phase II, post marketing medical device trials, 510K, PMA and
HDE (humanitarian device exemption) and similar clinical studies for US and international
regulatory submission.
TrialMed Life Sciences has successfully managed projects for clients needing everything from planning and monitoring to analysis and document preparation. At TrialMed, we believe that each client is unique, all clinical trials are different, and success hinges on flexibility. TrialMed is able to deliver customized services to each of our clients depending upon their strategic goals.
TrialMed Life Sciences LLC
59, Meadow Valley
Irvine, Ca 92602
Contact: Dr Raj Nihalani, MD, RAC(US)
Raj : 714-658-3039 (USA)
Email: Raj@trialmed.com or accessclinicaltrials@yahoo.com
Raj : 714-658-3039 (USA)
Email: Raj@trialmed.com or accessclinicaltrials@yahoo.com
Sonali Deshpande: 011-91-09892029644 (India)
