Our Services

1. Bio Availability/ Bio Equivalence (BA/BE) Studies in Healthy Subjects

Following activities are undertaken while performing BA/BE studies by Sarth Research Solutions LLP through selected CRO:

1. Prior study conduct

CRO qualification
Project Feasibility, Quotation Negotiation and CRO finalization
Protocol, ICF, CRF Review and Finalization
Coordinating with CRO/Sponsor for availability of WRS
Regulatory application submission and tracking of approval including Ethics Committee

2. During Study conduct

3. Post Study conduct

Retrospective audit of source documents and draft study reports
Review and finalization of clinical study report in eCTD including bio-analytical and statistical reports
Review and finalization of CDISC/ BTIF/ CSBE or any additional regulatory specific requirements
Addressing Sponsor or regulatory authority queries post to submission of final report

4. Project Management and Tracking

2. Pharmacokinetic/ Bioequivalence Studies in Patients

Following activities are undertaken while performing clinical trials (clinical end point and PK/patient-based BE) studies by Sarth Research Solutions LLP through selected Investigator and/CRO:

1. Prior Study Conduct

Investigator/ Site Selection
Project Feasibility, Quotation Negotiation and site finalization
Protocol, Informed Consent Form (ICF), Electronic Case Report Form (eCRF), Investigator's Brochure (IB), Clinical Trial Agreement (CTA), Review and Finalization
Collaborating with site investigators and trial sponsor to ensure that necessary resources and support
Regulatory application submission and tracking of approval including IRB approval

2. During Study Conduct

3. Post Study Conduct

Retrospective audit of sources/study documents
Review and finalization of clinical study report in eCTD including bio-analytical and statistical reports
Review and finalization of any additional regulatory specific documents
Addressing Sponsor or regulatory authority queries post to submission of final report

4. Project Management and Tracking

Overall project tracking from inception till submission of final report
Coordination with sponsor for availability of Investigational Medicinal Products (IMPs)
Coordinating with site investigator for patient recruitment to meet the study timelines
Coordinate with CRO for bioanalytical, statistical and draft/final clinical study report, in case of PK in patients

3. Regulatory (Standalone) Services

1. Local regulatory authority (DCGI)

CRO Registration and Re-registration
Import & Registration application for Pharmaceutical Products, Cosmetics and Medical Devices
Ethics Committee Registration and Re-registration
BENOC-TL and Import License Applications
Clinical Trial Applications, Participating in Subject Expert Committee and CT approval

2. CBN

3. Medical Writing

BE Study Protocol, ICF, CRF, Investigator Brochure etc.
Clinical Trial Protocol, ICF, CRF, Patient diary, Investigator Brochure etc.
Interim Report
Clinical Study Report
Translation of Patient Informed Consent, other supporting clinical documents
Poster and oral presentation
PSUR writing

4. Audits and Monitoring

CRO site selection Audit
Pre-Clinical site Audit
Standalone Bio-analytical site Audit
Hospital/CRO Phase- I site Audit
Site Initiation Visit and Site Close-Out Visit
In-process Clinical and Bio-analytical Monitoring/audits
Retrospective Audits
For-cause audit and Risk-based audits

4. Preclinical Studies

Following pre-clinical (toxicology and safety) studies are performed at selected pre-clinical CRO by Sarth Research Solutions LLP:

Toxicology Studies

1. In-Vitro and Genotoxicity Toxicity

2. In-Vivo – Toxicity

Acute Toxicity Studies
Repeated Dose Toxicity Studies (Rodent and Non-rodent)
Developmental & Reproductive Toxicology
Genetic Toxicity Studies
Micronucleus Test (MNT)
Chromosomal Aberration Assay
Immunogenicity Studies for Vaccines

3. Pharmacokinetic/Toxicokinetic Studies

4. Safety Pharmacology Studies

5. Dose-Range Finding Studies

6. Formulation and Delivery Studies

7. Immunogenicity Studies

8. Reproductive Toxicity Studies

9. Local Tolerance Studies

10. Mutagenicity

5. API/ Reference Product Sourcing

Support new generic product development by offering APIs and Reference Products from API manufacturing partners and Vendors respectively.

6. Dossier development

1. In-Licensing and Out-Licensing

Specialized expertise, knowledge, and resources through licensing in agreements.
Scientific and Technical Expertise
Support on Product in-licensing and out-licensing
Regulatory Assistance throughout the process
Provide marketing and commercialization support to help successfully launch and promote licensed products in target markets.
Post-Licensing Monitoring and Compliance

7. Formulation Development CMO/CDMO

Providing specialized services in the development of formulations for products in the pharmaceutical, biotechnology, nutraceutical, and healthcare industries.

1. CMOs

2. CDMOs

CDMO Identification and Qualification
Preformulation studies and Formulation optimization
Analytical method development and validation
Technology transfer and manufacturing of exhibit batch
Providing regulatory support

Our Services

1. Bio Availability/ Bio Equivalence (BA/BE) Studies in Healthy Subjects

1. Prior study conduct

2. During Study conduct

3. Post Study conduct

4. Project Management and Tracking

2. Pharmacokinetic/ Bioequivalence Studies in Patients

1. Prior Study Conduct

2. During Study Conduct

3. Post Study Conduct

4. Project Management and Tracking

3. Regulatory (Standalone) Services

1. Local regulatory authority (DCGI)

2. CBN

3. Medical Writing

4. Audits and Monitoring

4. Preclinical Studies

Toxicology Studies

1. In-Vitro and Genotoxicity Toxicity

2. In-Vivo – Toxicity

5. API/ Reference Product Sourcing

6. Dossier development

1. In-Licensing and Out-Licensing

7. Formulation Development CMO/CDMO

1. CMOs

2. CDMOs

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