“Company-sponsored research culminating into high-quality, peer-reviewed publications necessitates maintaining transparency and abiding to ethical standards for timely and effective scientific communication facilitated by publication professionals. Advances in the publication space such as evolving reporting guidelines, practical application of RWE information, public accessibility and data sharing recommendations can prove beneficial to HCPs, payers and several stakeholders with patients at the center of care.”

Dr. Vatsal Shah

Chief Operating Officer



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“Patient lay summaries in biomedical journals: what and how much is currently available?

Ramji will be delivering an oral presentation on the current status of ‘Patient lay summaries’ that are published in biomedical journals. As patients are at the core of clinical research, it is imperative that the research findings be transparently shared with them. The patient lay summaries provide an opportunity for patients to access the clinical research findings presented in a ‘non-technical’ or easily comprehensible plain language.

His study involved screening of biomedical journals for reported/published scientific information in patient lay summaries. A limited number of journals were found to publish these summaries and inconsistencies in the writing specifications were observed. Currently, there is a need for standardized reporting recommendations for such patient summaries in biomedical journals similar to Cochrane instructions. Patient involvement in developing these summaries was also noted as an added feature.

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Speaker profile - Ramji Narayanan

Ramji is an M Pharm in Pharmacology and and is a Certified Medical Publication Professional (CMPP) from ISMPP. He has over 8 years of experience in publication writing and medical communications and is currently working as Principal Publication Writer at SIRO Clinpharm Pvt Ltd. He has demonstrated a history of working in the Global pharmaceutical industry and for different clients in a CRO. He has gained extensive expertise in the publication process, writing/ reviewing various types of documents including primary/ secondary manuscripts, reviews, position statements, abstracts, posters, slide presentations, educational slide kits etc.

Ramji has a broad experience across several therapeutic areas, including infectious diseases, immunology, neurosciences, cardiology, endocrinology, musculoskeletal, and oncology. He has attended international conferences for coverage and worked on conference materials/ meeting reports; attended/presented at advisory board and KOL consensus meetings for publications development.

Ramji Narayanan

M Pharm, ISMPP CMPP™

“Patient lay summaries in biomedical journals: what and how much is currently available?”


ORAL PRESENTATION:
Wednesday, May 2, 2018 || 8:50am – 9:05am EST


Ramji will be delivering an oral presentation on the current status of ‘Patient lay summaries’ that are published in biomedical journals. As patients are at the core of clinical research, it is imperative that the research findings be transparently shared with them. The patient lay summaries provide an opportunity for patients to access the clinical research findings presented in a ‘non-technical’ or easily comprehensible plain language
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Ramji is an M Pharm in Pharmacology and and is a Certified Medical Publication Professional (CMPP) from ISMPP. He has over 8 years of experience in publication writing and medical communications and is currently working as Principal Publication Writer at SIRO Clinpharm Pvt Ltd. He has demonstrated a history of working in the Global pharmaceutical industry and for different clients in a CRO. He has gained extensive expertise in the publication process, writing/ reviewing various types of documents including primary/ secondary manuscripts, reviews, position statements, abstracts, posters, slide presentations, educational slide kits etc.
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“A consolidated checklist to standardize the reporting of real world evidence studies based on retrospective data analyses”

Retrospective data analysis (RDA) is the most common design of real world evidence (RWE) studies. The available recommendations for RDA are either focused on methodological quality or generalized for all designs of observational studies. Rishabh Pandey will be discussing a consolidated checklist, StRWE-Retro, constructed to standardize the reporting of RDA. The StRWE-Retro checklist showed good internal consistency.

He will also be discussing how this checklist can help publication writers improve the quality of RDA reporting on validation by a larger panel of experts.

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Speaker Profile - Rishabh Pandey

Rishabh Pandey holds a doctorate in Pharmacology. He is trained at the Indian Institute of Public Health for conducting meta-analysis and health economic evaluations and has also been certified on health technology assessments by the University of Sheffield. He has published & presented more than 30 papers in national/ international journals & conferences and reviewed manuscripts for leading publication houses like Elsevier, SAGE, Bentham science, Springer and Informa. His experience spans over a decade including academics, scientific communications and medical information. He has worked on numerous public health, epidemiology, real world evidence, health economics and outcome research projects.

He was part of GSK’s Global Medical Information and Scientific Affairs Department (GMISA) before he began his stint at SIRO almost 5 years back. In his tenure at SIRO, he has worked on more than 60 publications spanning various TAs like oncology, neurosciences, cardiovascular & outcome research for internationally reputed journals and international congresses.

Rishabh Pandey

M Pharm, Ph.D.

“A consolidated checklist to standardize the reporting of real world evidence studies based on retrospective data analyses”


POSTER (Guided Tour):
Tuesday, May 1, 2018 || 11:05am – 11:50am EST


Retrospective data analysis (RDA) is the most common design of real world evidence (RWE) studies. The available recommendations for RDA are either focused on methodological quality or generalized for all designs of observational studies. Rishabh Pandey will be discussing a consolidated checklist, StRWE-Retro, constructed to standardize the reporting of RDA. The StRWE-Retro checklist showed good internal consistency.
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Rishabh Pandey holds a doctorate in Pharmacology. He is trained at the Indian Institute of Public Health for conducting meta-analysis and health economic evaluations and has also been certified on health technology assessments by the University of Sheffield. He has published & presented more than 30 papers in national/ international journals & conferences and reviewed manuscripts for leading publication houses like Elsevier, SAGE, Bentham science, Springer and Informa. His experience spans over a decade including academics, scientific communications and medical information. He has worked on numerous public health, epidemiology, real world evidence, health economics and outcome research projects.
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“Safety reporting in publications of industry-sponsored clinical trials: Evaluation of adherence to adverse events reporting recommendations”

Sangita Patil will take you through her poster that evaluates the adherence to safety reporting recommendations like Medical Publishing Insights and Practices adverse events reporting recommendations and Consolidated Standards of Reporting Trials harms extension in industry-sponsored clinical trials publications. The credibility of safety reporting of clinical trials in scientific publications is often shrouded with suspicion as healthcare professionals desire an unbiased balanced representation of benefits versus risks to make appropriate choices of therapy.

Safety data reporting in publications of 85 phase 3, double-blind randomized-controlled clinical trials assessing efficacy/safety of interventions for diabetes mellitus (type 2) published in the last five years (2013 – 2017) were analyzed to gauge the extent of balanced reporting. The results of this analysis will guide physicians and medical publication professionals to identify the lacunae and prevent these lapses to enhance transparency in safety reporting of clinical trials.

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Speaker profile - Sangita Patil

Sangita comes with a rich 15+ years of scientific research experience. A PhD. in Biochemistry from Mumbai University and post-doctoral research experience in immunology from Mt. Sinai School of Medicine, NY and University of Pittsburgh, PA, US., Sangita is a Certified Medical Publication Professional (CMPP) from ISMPP. She has more than a decade of experience in writing and reviewing numerous industry sponsored publications, including a 5-year experience at SIRO. Her repertoire of document types ranges from primary manuscripts to reviews, meta-analysis, consensus guidelines and positioning statements.

She has numerous publications in peer-reviewed journals to her credit. Sangita has presented at national/ international advisory board/ KOL meetings and has conducted trainings for healthcare professionals in pharmaceutical industry for publication best practices, ICMJE and GPP guidelines. She serves as an SME at SIRO and is an active guide and faculty of the MW CHAMP (Coaching and Mentoring Programme for Medical Writers) at SIRO.

Sangita Patil

PhD, ISMPP CMPP™

“Safety reporting in publications of industry-sponsored clinical trials: Evaluation of adherence to adverse events reporting recommendations”


POSTER:
Monday, April 30, 2018 || 5:45pm – 6:45pm EST


Sangita Patil will take you through her poster that evaluates the adherence to safety reporting recommendations like Medical Publishing Insights and Practices adverse events reporting recommendations and Consolidated Standards of Reporting Trials harms extension in industry-sponsored clinical trials publications. The credibility of safety reporting of clinical trials in scientific publications is often shrouded with suspicion as healthcare professionals desire an unbiased balanced representation of benefits versus risks to make appropriate choices of therapy.
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Sangita comes with a rich 15+ years of scientific research experience. A PhD. in Biochemistry from Mumbai University and post-doctoral research experience in immunology from Mt. Sinai School of Medicine, NY and University of Pittsburgh, PA, US., Sangita is a Certified Medical Publication Professional (CMPP) from ISMPP. She has more than a decade of experience in writing and reviewing numerous industry sponsored publications, including a 5-year experience at SIRO. Her repertoire of document types ranges from primary manuscripts to reviews, meta-analysis, consensus guidelines and positioning statements.
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“Analysis of dissemination and accessibility of conference presentations”

Shweta, in her study, investigated the extent of post-congress archiving and public accessibility of conference presentations for neuroscience and oncology conferences. Archiving of important research findings presented at conferences and post congress allows access to research information until the final publication is available. This approach would ensure maximum transparency and timely disseminations of valuable data as encouraged by landmark guidelines convened by key stake holders involved in medical publications.

Limited online postings and accessibility of congress presentations were observed. Our poster sheds light on the dilemma that may exist among researchers regarding their commitment to transparent data sharing and apprehensions about posting naïve data for public access.

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Speaker Profile - Shweta Pitre

Shweta is a master’s in pharmacology with a research experience from King’s College, London, and is a Certified Medical Publication Professional (CMPP) from ISMPP. With an enriched background of drug discovery and development, she has a 5-year experience in writing/ reviewing varied publications including primary/ secondary manuscripts, narrative/ systematic reviews and meta-analysis, consensus statements, congress deliverables (abstracts, posters and slide-decks) and has effectively covered KOL meetings for various pharma clients.

She also received a formal regimented training (at Kings College, London) on literature search strategies/ advanced indexing tools/ databases for publications. She has worked across diverse therapeutic areas including diabetes and cardiovascular metabolism, infectious diseases and virology, oncology, immunology and neurosciences. Shweta is actively involved in training and mentoring of budding publication writers at SIRO.

Shweta Pitre

M Pharm, ISMPP CMPP™

“Analysis of dissemination and accessibility of conference presentations”


POSTER:
Monday, April 30, 2018 || 5:45pm – 6:45pm EST


Shweta, in her study, investigated the extent of post-congress archiving and public accessibility of conference presentations for neuroscience and oncology conferences. Archiving of important research findings presented at conferences and post congress allows access to research information until the final publication is available. This approach would ensure maximum transparency and timely disseminations of valuable data as encouraged by landmark guidelines convened by key stake holders involved in medical publications.
Read more

Shweta is a master’s in pharmacology with a research experience from King’s College, London, and is a Certified Medical Publication Professional (CMPP) from ISMPP. With an enriched background of drug discovery and development, she has a 5-year experience in writing/ reviewing varied publications including primary/ secondary manuscripts, narrative/ systematic reviews and meta-analysis, consensus statements, congress deliverables (abstracts, posters and slide-decks) and has effectively covered KOL meetings for various pharma clients.
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“SIRO drives its wheel of progress in varied arenas of scientific and medical publications with its well-trained, process-compliant, customer-centric team of publication specialists”