Clinical Development Services
Syngene strives to attract and retain the best talent in the industry and back them up with world class infrastructure and systems. All the laboratories are equipped with high-end instruments and equipment to support various research and development activities. We have well established systems to maintain data confidentiality while working with multiple clients and built an impeccable track record over the last 15 years. We have implemented a comprehensive business continuity and disaster recovery plan.
Human Pharmacology Studies
Syngene's Human Pharmacology Unit (HPU) was established in 2004 for conducting clinical studies in healthy human volunteers.
The HPU has expertise in conducting studies on various dosage forms such as tablets, capsules, extended release preparations, nasal preparations, inhalations, injectable, patches and topical creams etc.
The HPU team comprises experienced investigators, project managers, duty doctors, quality control personnel, pharmacists, dieticians, custodians, counsellors, nurses, laboratory technologists, phlebotomists, volunteer coordinators and non-technical staff.
The HPU’s pharmacy is well equipped with temperature/humidity chambers, laminar air flow, refrigerator that maintains a constant temperature of 40C, weighing balance, mechanical shaker, monochromatic light, synchronized clock and computer system with access to only authorized personnel such as the pharmacist, and maintenance teams. It has CCTV coverage throughout the facility and the humidity and temperature of the entire facility is monitored by a specialized software based data logger.
The HPU’s ICU is well equipped with advanced instruments including the emergency crash cart, telemetry, suction pump, infusions pumps, oxygen cylinders, defibrillators, ambu bag, ECG machine, resuscitation kit, infusomat pump, YSI glucose analyser, nebulizer, sure temp plus thermometer, pulse oximeter etc. and emergency medicines. To manage any emergency, the HPU has dedicated staff trained in ACLS and BLS and a tie-up with a super speciality hospital located about 3 kilometers away from the facility. Syngene’s HPU also has a fully equipped ambulance on stand-by at all times for shifting study subjects to hospital in case of an emergency.
Equipped with the cutting edge instrumentation, advanced techniques and the latest technology platforms, Syngene's laboratories offer a comprehensive set of advanced services that help reduce lead-in times and meet deadlines. All the labs are equipped with state-of-the-art infrastructure that can be leveraged to perform diagnostic assays to support end-to-end trial management.
Bioanalytical Laboratory for Small Molecules
Syngene’s Bioanalytical Laboratory for Small Molecules is spread over an area of 7500 sq. ft. and equipped with state-of-the-art instrumentation (with qualification) comprising:- LC-MS / MS (API 4000 and API 4000 QTrap) with ESI and APCI sources.
The lab’s software applications include:
- Analyst® ( LC-MS / MS ) and LightSight® ( for metabolite identification )
- Empower ( HPLC and UPLC )
- Watson LIMS™ ( Laboratory Information Management System )
- Phoenix® WinNonlin® 6.2 for pharmacokinetic analysis
Bioanalytical Laboratory for Large Molecules
Syngene’s Bioanalytical Laboratory uses comprehensive immunoassay techniques to cater all phases of biologics drug development.
Syngene has the necessary infrastructure and technical expertise to support the following assays:
- Cell-based assays
- Fluorescence-activated cell gating and enumeration
- Fluorescence and absorbance based assays
Syngene’s Bioanalytical Laboratory has state-of-the-art instruments and equipment comprising:
Meso Scale DiscoverySector Imager 2400 and Sector Imager 6000
- ELISA Plate readers and washers:
- Synergy 2 and Synergy HT: (Biotek) UV, Visible, Fluorescence
- Spectramax PLUS® 384 (Molecular Devices) UV, Visible
- Infinite 200 (Tecan) UV, Visible, Fluorescence
- Biotek, ELX405Beta Counter:
Chameleon, VLSC 425-158 (Hidex OY) Liquid Scintillation
- Gamma Counter:
- Wizard 2, 2470-0020 Automatic with 2 detectors (Perkin Elmer)
- Wizard 2, 2470-0020 Automatic with 5 detectors (Perkin Elmer)
- Surface Plasmon Resonance:
- Biacore T-100 (GE Healthcare)
- Cell Harvester: Filtermate (Perkin Elmer)
- Water Purification System:
- Milli-Q Intergral 3 (Millipore)
- Software and Laboratory Information Management System
- Watson LIMS™ (Laboratory Information Management System)
Instrument software validated according to international regulations including 21 CFR part 11
- Liquid handling systems:
- Tecan Genesis Freedom 150/8 workstation Platform
- Tecan Freedom Evo 150/8 workstation Platform
- Ultra Low Temperature Freezers(Thermo scientific and Nuaire)and Refrigerators:
- connected to Temperature Monitoring Alarm System Sensaphone)
Syngene’s Central Laboratory is equipped with the necessary infrastructure expertise to support:
- Phases I-IV clinical trials
- BA/BE studies
- Establishment of new assays and validations to meet client requirements
- Clinical trial testing especially in areas such as diabetes, cardiovascular, oncology and immunology.
- Spacious 8000 sq. ft. campus
- Access controlled facility
- Wireless data logging system for remote control of temperature and humidity
- Well placed alarm systems
- Contractual arrangements for biological waste disposal
Clinical Trial Management
Our facility has a separate 700 sq. ft. access-controlled, clinical supplies unit that maintains temperatures between -15 to -25°C, 15 to 20°C and 2 to 8°C. This unit has an electronic temperature monitoring system along with an auto alarm system.
To prevent degradation of clinical trial supplies, Syngene partners with reliable cold chain logistics solution providers to ship supplies in stable refrigerated conditions to the investigation sites.
Syngene has set up a secure project-specific portal, ‘Syng Connect’, to share, exchange and archive vital documents quickly. The portal is equipped with version control tools to track changes made by different team members on live projects. This helps project teams to collaborate and share the documents in real time, obviating the need to physically travel to the office to check the filing system.
Medical Writing & Medical Monitoring Services
Syngene's clinical development services unit is equipped with robust IT solutions and expert resources to execute projects efficiently.
To improve collection, consolidation, analysis and reporting of clinical data, Syngene's clinical data management and biostatistics team utilizes essential tools including:
SAS PheedIt (21 CFR, Part 11) for data capture and validation for EDC and paper based studies
SAS Analytics for statistical analysis
Adobe PageMaker for CRF designing
MedDRA® for adverse event coding
WHO-DD for medication coding
Phoenix® WinNonlin®. for PK/PD modeling and non-compartmental analysis