clinical research services

Lotus Labs Pvt Ltd. offers Clinical Research Services, a solution designed to provide a wide range of services for clinical research to pharmaceutical, biotech, and medical device companies. According to the vendor, this product caters to the needs of global companies in these industries, including pharmaceutical, biotechnology, and medical device sectors, contract research organizations (CROs), and academic research institutions.

Key Features

BA/BE Studies: According to the vendor, this product allows users to conduct bioavailability and bioequivalence studies in compliance with international regulatory requirements. The vendor specializes in method development and validation for bioanalytical services.

PK PD and Patient Studies: The vendor states that this product enables users to conduct PK studies and provides data analysis, statistics, and reporting. They also specialize in studies on patient populations and special populations, with expertise in handling various matrices such as plasma, serum, and whole blood.

Bioanalytical Services: According to the vendor, this product offers comprehensive bioanalytical services for pharmaceutical and biotechnology companies. They develop and validate over 600 bioanalytical methods for various human matrices, utilizing state-of-the-art laboratories and equipment, including LCMS/MS systems.

Assay Bank: The vendor claims to develop and validate over 450 bioanalytical methods for leading pharmaceutical companies. They offer a wide range of assays for various therapeutic areas and provide quick turnaround times for method development and validation. They also have expertise in handling various matrices and performing simultaneous analysis of multiple compounds.

Phase I Studies: According to the vendor, this product allows users to conduct phase I studies on healthy volunteers. They offer capabilities for dose escalation studies and specialized clinical pharmacology studies. The product also provides infrastructure and expertise for food effect, proof of concept, and drug interaction studies.

Phase II-IV: The vendor states that this product demonstrates leadership and a proven track record in conducting clinical trial phases. They establish strategic relationships with reputed hospitals and clinical sites and conduct multi-centric, multi-national clinical trials with patient groups ranging from 15 to 1500. The product offers a comprehensive range of services, including investigator/site identification, patient recruitment, data management, and medical monitoring.

Biometrics Services: According to the vendor, this product offers a highly competent biometrics services group that supports clients at all clinical trial phases. Their services include protocol writing, statistical analysis, and report writing. They are equipped with the latest software like WinNonLin and SAS.

Comprehensive Clinical Data Management: The vendor claims that this product allows users to transform raw data into consistent, accurate, and reliable trial outputs in compliance with regulatory guidelines. It is designed to expedite the regulatory submission process and shorten timelines. The product also has capabilities to manage multi-centric studies for domestic and global requirements in different therapeutic areas.

Medical Writing Services: According to the vendor, this product provides a qualified and experienced medical writing team that complies with regulatory report guidelines. They offer clear, concise, and accurate regulatory submission documents, including protocol, investigation brochures, informed consent documents, study reports, and scientific papers.

Regulatory Services: The vendor states that this product offers in-depth knowledge of local regulatory procedures and efficient liaison with various regulatory agencies. Their services include formulation of regulatory strategies, compilation of clinical trial applications, response to regulatory agency queries, and safety reporting.