Phase I and Bioequivalence Studies
- Capabilities
- Infrastructure
- Experience
- Services
- Why us?
Medical Writing
- Capabilities
- Services
- Why us?
Phase I and Bioequivalence Studies:
 
bullet Capabilities:
 
bullet Protocol development, IEC submissions and approvals
bullet Conduct studies with males and females, special population
bullet Conduct Phase I (First-in-Man) with extensive monitoring and Bioequivalence Studies
bullet Handle different dosage forms including oral thin films (OTF), oral dispersible tablets (ODT), suppositories, inhalers, injections, etc.
bullet Conduct QT studies with replicate ECGs and ECG Core Laboratory
bullet A rigorous QC team to ensure data integrity
 
bullet Infrastructure:

bullet Access to 457 beds at Ahmedabad, Mumbai and Warsaw facilities equipped with bedside bells, CC TVs and Recreation Facilities for volunteers
bullet State of the art ICU for Phase - I studies equipped with GE DASH 4000, MAC 1200, MAC 5500, Central Monitoring system, telemetry and Holters
bullet GE MUSE system –computerized ECG management systems
bullet Well equipped medical screening and emergency facilities including in-house X-ray, Ultra sonography, Defibrillators with transcutaneous cardiac pacer, cardiac monitors
bullet Dedicated Pharmacy with Temperature & Humidity control chambers and separate dispensing area
bullet Experience:

bullet Expertise in BA/BE studies for various global regulatory bodies including US FDA, EU, TGA, CANADA and ANVISA

List of Project conducted from 1999 to 2008
Total no. of BA/BE studies conducted = 1000
Total no. of Phase I conducted = 20

bullet Services:
 
bullet BA/BE studies for Global Submission
bullet Phase I studies (First time in Man)
bullet Drug-Drug Interaction studies
bullet Thorough QT-QTc studies
bullet Proof of concept studies
bullet Safety and tolerability studies
bullet Studies in special population
bullet PK studies in patients
bullet Dedicated Medical Writing Team
 
bullet Why us?

bullet Over 800 studies in healthy volunteers
bullet Robust system and open to adapt to client requirements
bullet Large bed capacity (457 beds)
bullet Data base of over 28,000 healthy volunteers
bullet Dedicated QC team
bullet Experienced team ensures delivering on time with high quality

 
Medical Writing:
 
bullet Capabilities:
 
bullet Protocols/Investigator’s brochure
bullet Integrated clinical study reports (Phases I to IV)
bullet Clinical/non clinical sections of common technical document (ctd)
bullet Abstracts, manuscripts and poster presentations
 
bullet Services:

bullet To organize, write, edit and compile the range of medical and scientific documentation
bullet Why us?:

bullet A strong team of qualified and experienced medical writers with Ph.Ds & MD Physicians with specialization in Pharmacology, Medicine, Pathology

 

Lambda Therapeutic Research Ltd.
A CRO for Clinical Research, Clinical Trials, Medical Writing, Bioanalytical, Bioequivalence and Pharmacovigilance services.
India (Ahmedabad - Mumbai), Poland (Warsaw), USA