Clinical Research Department (LSSH-CRD)
Advancing Healthcare through Evidence-Based Research
Established in 2009
About the Clinical Research Department
The Clinical Research Department at Lalitha Super Specialities Hospital (LSSH-CRD) is committed to advancing medical knowledge and improving patient outcomes through high-quality clinical research. Since its establishment in 2009, the department has actively collaborated with leading pharmaceutical companies, government bodies, global research organizations, and academic institutions.
Our mission is to promote excellence in clinical research while ensuring uncompromised patient safety, ethical standards, and scientific integrity.
Why Choose LSSH-CRD for Clinical Research?
Experience & Expertise
- Led by GCP-trained Principal Investigators with extensive clinical and research experience.
- Supported by a full-time, dedicated, GCP-certified research team.
State-of-the-Art Research Infrastructure
- Spacious and secure research facility
- Dedicated areas for documentation, investigational product storage, audits, and long-term archiving
- Robust data management and study-conduct systems
Compliance & Quality
- Up-to-date SOPs aligned with national and international regulatory guidelines
- All trials approved and periodically reviewed by a NABH-accredited Institutional Ethics Committee (IEC)
- Compliance with ICH-GCP, DCGI and sponsor-specific quality requirements
Clinical Trial Phases Explained
We conduct trials across all phases:
- Phase I: Safety evaluation in healthy volunteers
- Phase II–III: Safety, efficacy, and optimal dosage assessment
- Phase IV: Post-marketing, long-term safety data collection
Each study is conducted under strict protocols and regulated by:
- Drug Controller General of India (DCGI)
- Institutional Ethics Committee (NABH Accredited)
- Sponsor/CRO monitoring teams
Areas of Research Expertise
Cardiology Clinical Trials
Our Cardiology Division has conducted multiple phase III, and IV clinical trials in areas such as:
- Acute Coronary Syndrome
- Myocardial Infarction
- Congestive Heart Failure
- Atrial Fibrillation
- ASCVD risk
- Large epidemiological and preventive cardiology studies
Cardiology – Completed & Ongoing Trials
Principal Investigator: Dr. P. V. Raghava Sarma, M.D., D.M.
| S # | Indication | Phase | CRO / Sponsor | Year |
|---|---|---|---|---|
| 1 | Critical Illness | IV | Reliance Clinical Research / Sanofi Aventis | 2009 |
| 2 | Cardiovascular Diseases (POLYPILL) | III | George Institute / Imperial College London | 2010 |
| 3 | Acute Coronary Syndrome | III | Quintiles / Eli Lilly | 2010 |
| 4 | Congestive Heart Failure (ATMOSPHERE) | III | Novartis | 2012 |
| 5 | Post MI (CANTOS) | III | Novartis | 2013 |
| 6 | Yoga-Based Cardiac Rehabilitation | NA | CCDC | 2014 |
| 7 | Atrial Fibrillation (GARFIELD–AF) | IV | Quintiles / Thrombosis Research Institute | 2014 |
| 8 | Congestive Heart Failure (PARADIGM-HF) | III | Novartis | 2015 |
| 9 | COPD + High Risk of Cardiovascular Disease | III | Parexel / GlaxoSmithKline | 2015 |
| 10 | Congestive Heart Failure (PARAGON-HF) | III | Novartis | 2015 |
| 11 | Congestive Heart Failure (Co-Investigator) | III | Novartis | 2016 |
| 12 | Established Cardiovascular Diseases (Epidemiological Study) | NA | Novartis | 2017 |
| 13 | Established Cardiovascular Diseases (Heritage Study) | III | Novartis | 2017 |
| 14 | Compare Clinical Outcomes of PCI (TUXEDO 2 Study) | III | Batra Hospital & JSS Research | 2018 |
| 15 | Established Cardiovascular Diseases (Horizon Study) | III | Novartis | 2019 |
| 16 | Acute Myocardial Infarction | III | Hetero Biopharma | 2020 |
| 17 | Established Cardiovascular Disease (VICTORION-2 PREVENT) | III | Novartis | 2022 |
| 18 | Established Cardiovascular Disease (VICTORION-1 PREVENT) | III | Novartis | 2023 |
| 19 | Heart Failure (HERMES) | III | Novo Nordisk | 2024 |
| 20 | Acute Myocardial Infarction (ARTEMIS) | III | Novo Nordisk | 2024 |
| 21 | Established Cardiovascular Disease + CKD + Systemic Infection (ZEUS) | III | Novo Nordisk | 2023 |
| 22 | Established Cardiovascular Disease (REDEFINE III) | III | Novo Nordisk | 2023 |
| 23 | Acute Myocardial Infarction | IV | Hetero Biopharma | 2025 |
| 24 | Acute Myocardial Infarction (SOS-AMI) | III | IQVIA / Viatris | 2025 |
Neurology Clinical Trials
Our Neurology Division is recognized nationally for its contributions to stroke research and other neurological disorders, including:
- Ischemic & Hemorrhagic Stroke
- Parkinson's Disease
- Epilepsy (Partial & Generalized Seizures)
- Migraine
- Stroke Rehabilitation
- INSTRUCT network studies
Neurology - Completed & Ongoing Trials
Principal Investigator: Dr. P. Vijaya, M.D., D.M.
| Sr# | Indication | Phase | CRO / Sponsor | Year |
|---|---|---|---|---|
| 1 | Ischemic Stroke (REGENESIS study) | IIb | Maya Clinicals / Stem Cell Therapeutics | 2009 |
| 2 | Partial Onset Seizures | III | Torrent | 2010 |
| 3 | Hemorrhagic Stroke (INTERACT 2) | III | George Institute for Global Health | 2010 |
| 4 | Partial Onset Seizures | IV | Novartis | 2010 |
| 5 | Shoulder Taping (TAPING study) | NA | CMC Ludhiana | 2010 |
| 6 | Ischemic Stroke (DIAS 3) | III | Quintiles / Lundbeck | 2011 |
| 7 | Parkinson’s Disease (BIPARK study) | III | Quintiles / BIAL | 2011 |
| 8 | Partial Onset Seizures | III | Parexel / Pfizer | 2011 |
| 9 | Ischemic Stroke | III | Reliance | 2012 |
| 10 | Generalized Tonic Clonic Seizures (TEAM study) | IV | Novartis | 2013 |
| 11 | Stroke Rehabilitation (ATTEND trial) | NA | CMC Ludhiana / George Institute | 2013 |
| 12 | Ischemic Stroke (TENECTEPLASE) | III | Emcure Pharmaceuticals | 2014 |
| 13 | Secondary Stroke Prevention (RE-ESPECT ESUS) | III | Boehringer Ingelheim | 2015 |
| 14 | Ischemic Stroke (ENCHANTED) | NA | CMC Ludhiana & George Institute | 2016 |
| 15 | Ischemic Stroke (THALES study) | III | AstraZeneca | 2018 |
| 16 | Ischemic Stroke | IV | Emcure Pharmaceuticals | 2018 |
| 17 | Migraine (EMPOWER study) | III | Novartis | 2018 |
| 18 | Stroke (SPRINT study) | NA | INSTRUCT Network & ICMR | 2018 |
| 19 | Ischemic Stroke (AVERT-DOSE) | NA | INSTRUCT Network | 2020 |
| 20 | Ischemic Stroke (PMZ-1620) | III | Pharmazz India Pvt. Ltd. | 2020 |
| 21 | Ischemic Stroke (ELAN) | III | Inselspital, University Hospital Bern | 2021 |
| 22 | Hemorrhagic Stroke (INTRINSIC) | NA | INSTRUCT-2 Network | 2022 |
| 23 | Ischemic Stroke (RE-OPEN) | NA | INSTRUCT-2 Network | 2022 |
| 24 | Ischemic Stroke (STENOSIS) | NA | INSTRUCT-2 Network | 2022 |
| 25 | Stroke (MOBILITY) | NA | INSTRUCT-2 Network | 2022 |
| 26 | Ischemic Stroke (PROLEVIS) | NA | AIIMS, New Delhi | 2022 |
| 27 | Ischemic Stroke (PROLEVIS CVT) | NA | AIIMS, New Delhi | 2022 |
| 28 | Hemorrhagic Stroke + AF (ENRICH AF) | NA | Population Health Research Institute, Hamilton, Canada | 2023 |
| 29 | Ischemic Stroke (OCEANIC STROKE) | III | Bayer | 2024 |
| 30 | Menstrual Migraine | III | Pfizer | 2025 |
| 31 | Ischemic Stroke (ACT GLOBAL) | NA | University of Calgary & George Institute for Global Health | 2025 |
| 32 | Hemorrhagic Stroke (BEAT-ICH INDIA) | NA | INSTRUCT-2 Network | 2025 |
Key Publications
The Clinical Research Department has contributed to multiple high-impact national and international publications, including:
- The New England Journal of Medicine
- The Lancet
- JACC
- AHA/ASA Journals
- JAMA Neurology
- BMJ Stroke Journal
- European Stroke Journal
Below are key peer-reviewed publications contributed through studies conducted at LSSH - Clinical Research Department in Cardiology and Neurology.
Cardiology Publications
- https://www.ncbi.nlm.nih.gov/pubmed/28845751
- https://www.ncbi.nlm.nih.gov/pubmed/24002278
- https://www.ncbi.nlm.nih.gov/pubmed/31475794
- https://www.ncbi.nlm.nih.gov/pubmed/25176015
- https://www.ncbi.nlm.nih.gov/pubmed/27043774
- https://www.jacc.org/doi/full/10.1016/j.jacc.2020.01.050
Neurology Publications
- http://onlinelibrary.wiley.com/doi/10.1111/j.1747-4949.2007.00089.x/abstract
- http://www.ncbi.nlm.nih.gov/pubmed/21427453
- http://medind.nic.in/ice/t12/i8/icet12i8p324.pdf
- http://www.ncbi.nlm.nih.gov/pubmed/23345636
- http://onlinelibrary.wiley.com/doi/10.1111/ijs.12260/abstract
- http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)31447-2/fulltext
- https://doi.org/10.1007/s40256-018-0284-1
- https://www.nejm.org/doi/full/10.1056/NEJMoa1916870?query=featured_home
- https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(22)00544-7/fulltext
- https://pubmed.ncbi.nlm.nih.gov/36478762/
- https://www.nejm.org/doi/full/10.1056/NEJMoa2303048
- https://jamanetwork.com/journals/jamaneurology/article-abstract/2819377
- https://doi.org/10.1161/CIRCULATIONAHA.124.069324
- https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.124.069324?doi=10.1161/CIRCULATIONAHA.124.069324
- https://karger.com/ced/article-abstract/doi/10.1159/000545675/925757/Comparing-Stroke-Profiles-and-Outcomes-between
- https://pubmed.ncbi.nlm.nih.gov/40335450/
- https://pubmed.ncbi.nlm.nih.gov/40387006/
Our Commitment
At LSSH-CRD, we strive to:
- Advance medical science
- Build collaborative global research partnerships
- Ensure the highest ethical and scientific standards
- Contribute to meaningful health outcomes for patients and communities
Contact Us
Clinical Research Department, LSSH
Nagamalleswararo Tagallamudi
Site Manager - Clinical Research
+91 98663 91141
nagalssh@gmail.com
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