With 17 years of excellence in research, Cliantha offers wide array of early phase services accomplished by our trained professionals. These services can be accessed as part of an integrated program or as a stand-alone service at our clinical or multicentric sites
In various types of studies
Parallel, Cross over, Partial Replicate and Full Replicate
Fasting, Fed & Sprinkle Applesauce
Long housing (confinement up to continuous 17 days)
Studies demanding frequent blood sampling, long washout up to 45 days, continuous monitoring.
Multiple dose studies with 5 - 7 consecutive daily dosing
Hospital set-up BE studies
Various Routes of Administration (dosage forms)
- Injection (IM, IV, Subcutaneous)
- Oral (Tablets: IR,ER,SR,MR,CR,DR,ODT,Chewable)
- Capsules: ER,MR,DR, Soft Gelatin)
- Rectal (Suppository & Foam)
- Transdermal (Patch, Topical Cream, Topical Gel, Lotion)
- Vaginal (Tablet, Cream, Gel)
- Pulmonary (MDI & Nasal Spray)
BA/BE-Phase 1 Achievements
- 100+ derma/patch BE Studies (Adhesion/PK)
- Successfully conducted the Open First to File study across different Cliantha's geographical locations for Clinic (US), Lab (Canada), PK and Report (India).
- Liposomal Amphotericin B 50 mg injection pivotal study which involves challenges like continuous and precise IV infusion over 2 hours with the help of calibrated infusion pump and possibilities of more adverse events including infusion related reaction which were prevented/well managed with IV ConMed.
- Diclofenac Sodium 37.5 mg/ml injection PK/PD pivotal study which demands very frequent sampling for initial few minutes and PD parameters to be analyzed within 01 to 02 minutes after blood collection.
- Inhalation study on Ipratropium Bromide HFA Inhalation Aerosol 21μg. The study demands extensive training of volunteers with placebo. Specially designed negative pressure rooms were used for dosing to avoid cross contamination
- 70+ studies with continuous cardiac monitoring studies (Ranolazine, Propafenone, Flecainide etc.)
- 40+ long housing studies (Potassium Chloride/Citrate)
- 88 studies (62 pivotal, 26 pilot) for long washout (Levothyroxine, Enzalutamide, Aripiprazole, Empagliflozin and Linagliptin, Brexpiprazole etc.)
- 154 studies (118 pivotal, 36 pilot) for hormonal preparation(Ethinyl Estradiol+Levonorgestrol, Desogestrel+ Ethinyl Estradiol, Levothyroxine, Methylprednisolone, Prednisolone, Hydrocortisone, Liothyronine, Drospirinone+Ethinyl Estradiol, Norethindrone Acetate +Ethinyl Estradiol etc.)
- 45 studies in elderly population (Brexpiprazole and Aripiprazole)
- Phase I, multiple dose, placebo controlled study to evaluate the safety and tolerability of topical cream having long housing of 15 days
- 06 sublingual tablets studies (Nitroglycerin 0.6 mg) demanding frequent blood sampling
- 12 studies for biosimilars (Darbepoetin, Enoxaparin, Pegfilgrastim, Repoitin, Adalimumab, Trastuzumab etc.)
- Studies with stringent screening criteria, long housing, long washout, high sample size etc (Pegfilgrastim)
- 02 studies (01 pilot, 01 pivotal) for Octreotide depot injection having higher sample size (n=220) and 70 days last ambulatory samples
Cliantha’s team of very experienced and highly trained medical writers are responsible for preparing the study protocols in line with the sponsor’s requirements and applicable regulatory guidance. The medical writing team also coordinates with the ethics committee for the necessary approvals
- Protocol development
- Protocol amendments
- Informed Consent Forms
- Case Report Form preparation
- Clinical study reports
- Bioanalytical sample analysis reports
- Method validation report
- Biostatistical reports
Our medical writing services are in full compliance with applicable regulatory requirements.
Location: Ahmedabad, Vadodara, Noida
- 12 clinical units, 513 beds, 14 ICU beds & 25 doctors
Location: St. Petersburg, FL & Mississauga
- 4 clinical units, 147 beds, 19 ICU beds
- Complete On-Site Pharmacy
Cliantha research provides scientific expertise with state-of –the-art technologies reinforced by commitment for quality delivery. Our comprehensive lab services include bioanalytical, central lab testing, PK services, immunogenicity testing etc.
Biometrics is one the centre's of excellence that Cliantha research excels into. With more than 15 years of experience, we have been successful in carving the niche for ourselves. With more than 100 trained professionals, biometric team provides efficient and cost effective outsourcing solutions for Clinical Data Management, Biostatistics & Programming and CDISC.
Cliantha Research has been successfully inspected or audited by various regulatory agencies across the globe. Our impeccable regulatory track record is the result of strict adherence to the applicable standard(s) and guidelines laid by ICH, FDA, EMA, Clinical and Bio-Analytical bodies. Our enshrined values : Science & Integrity are the foundation for our planning and execution assisted with robust knowledge of the regulations.