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Scientific Writing and Communications

Scientific Writing and Communications at SIRO
A fully-evolved team of dedicated medical writers across three continents with a base in India is experienced across all therapeutic areas including niche areas like vaccines, and all phases of clinical research including bioequivalence and preclinical. This medical writing team has delivered high-quality regulatory documents ranging from IBs and protocols through clinical narratives and aggregate reports like ASRs/ DSURs to CSRs and eCTD components, and peer-reviewed publications eventually published in indexed journals with high impact factors, including abstracts and posters for global congresses.

Our year-on-year participation at various national and international conference have always been well received and appreciated. Recognition at international platforms include multiple poster and podium sessions encompassing novel and revolutionary topics on medical writing. Our latest study presented at the prestigious ISMPP (International Society for Medical Publications Professionals) conference 2016 has been cited by the Joint Position Statement on Professional Medical Writers by AMWA, EMWA and ISMPP, released in January 2017, a feat that truly goes to show the expertise and knowledge we bring to the table.

Click here to view the joint position statement (reference 17)

Read about our Publication Writing Services

Read about our Medical Communications Services

Read about our HEOR Publication Capabilities

Raison d'etre
The key to professional success for researchers is the precise presentation of scientific ideas and results, which helps maximize the accuracy and impact of written documents. Although medical and clinical research professionals are experienced in the fields of medical and clinical research, expertise in the field of regulatory science writing and publication of scientific papers is still a gap, and SIRO has converted this into an asset by instituting a dedicated medical writing group.

Resource Pool
SIRO's medical writing talent pool is a unique blend of medically qualified (including post-graduates) and para-medical (PhD, pharmacists) skilled writers hailing from academics, clinical research, clinical practice and the pharma industry.

The team possesses strong analytical and interpretation skills, comes with a thorough knowledge of experimental design and biostatistics, demonstrates good exposure to standard editorial/ style conventions, and is highly proficient in computer word processing programs. Writers who lead and manage the teams are hand-picked and remain hands-on considering the domain-intensive nature of the job.

Our services offered
The overall scope of work includes all of the following, but not limited to:
  • Peer-reviewed Publications (from publication planning to journal/ congress submissions)
  • Abstracts, posters (content and layout), slidesets, conference coverage
  • Patient narratives, integrated safety summaries, aggregate reports (DSURs, PSURs)
  • Clinical study reports (ICH E3), eCTD components (module 2.7, Table of all studies)
  • Consent documents
  • Statistical analysis plan in conjunction with biostatisticians
  • Clinical study protocols, clinical study synopses
  • Investigators' brochures
  • Feasibility survey reports, disease demographics from India and Europe

Our experience
SIRO's medical writing group is currently engaged in preparation of essential documents for clinical trial submissions and other paraphernalia associated with clinical research. These include investigators' brochures, protocols, consent documents, patient narratives, clinical study reports, selected eCTD modules, development safety update reports (DSURs), periodic safety update reports (PSURs) and annual safety reports (ASRs). Till date the group has delivered an unparalleled number of these documents across all major therapeutic areas including niche areas like immunology and vaccines.

Our medical writing team has also delivered high-quality manuscripts eventually published in indexed journals with high-impact factors like Nature Reviews Neuroscience, JAMA, Journal of Clinical Oncology, Journal of Allergy and Clinical Immunology, Biological Psychiatry, Neurology, Clinical Cancer Research, Annals of Oncology, Journal of American Academy of Child and Adolescent Psychiatry, Clinical Pharmacokinetics, International Journal of Neuropsychopharmacology, Pediatrics, Bipolar Disorders, Epilepsia, Journal of AIDS, Progress in Neuropsychopharmacology & Biological Psychiatry.

Abstracts and posters are regularly prepared and submitted for global congresses like American Association for Cancer Research (AACR), American Academy of Neurology (AAN), American College of Neuropsychopharmacology (ACNP), American Psychiatric Association (APA), Australasian Prostate Cancer Conference (APCC), American Society of Clinical Oncology (ASCO), American Society of Hematology (ASH), World Congress of Neuropsychopharmacology (CINP), European College of Neuropsychopharmacology (ECNP), European Haematological Association (EHA), European Society for Medical Oncology (ESMO), North American Society for Pediatric Gastroenterology, Hepatology and Nutrition, (NASPGHAN), Society of Biological Psychiatry (SOBP).

Our medical writing horizon is expanding to include medical communications services that allow pharmaceutical companies to better educate Health Care Professionals, pharmaceutical sales representatives and more importantly educate patients.

SIRO ranks high amongst the few full service organizations that offer these services across the entire spectrum of clinical research, spanning from early, including clinical monitoring, to advanced development (phases I through IV), including bioavailability/ bioequivalence and post-marketing study/ surveillance.

Key differentiators
  • Compliance with regulatory requirements for FDA, EMEA, others
  • Trained on ICH GCP principles, Writing styleguides (like AMA), reference managers like endnotes and medical dictionaries like MedDRA/ WHODD as necessary
  • Specific writers trained on publication-related standards like GPP, ICMJE , CONSORT, QUORUM, MOOSE, STARD, STROBE, TREND, ethical considerations in the conduct and reporting of research
  • Robust quality management systems with use of defect trackers and Pareto analysis followed by CAPA integrated within the working processes
  • Comprehensive training plan for induction as well as on-going refresher ones
  • Culture of lessons learnt and innovation, training on lean and six-sigma
  • Maintenance of author wise, molecule wise, phase wise, program wise trend sheets

Working models
Our services are available as stand-alone medical writing projects as well as part of comprehensive full-scope clinical trial management program. We are flexible to provide medical writing services with quick ramp-up capability for various service delivery models like:
  • Individual project outsourcing models
  • Dedicated FTE business models
  • FSP business model

Our team has expertise in working on client systems & SOPs, and web based document management systems, apart from SIRO's regulatory-compliant SOPs & processes. This helps clients to have the document worked upon 24 X 7, & finalize the documents with critical timelines at the earliest. We cross-train our resources across different therapeutic areas and document types to maintain buffers & manage attrition effectively.

Data Security
We understand the criticality of confidentiality of information & data security in medical writing for our clients. Hence our IT security procedures are benchmarked with best practices across the globe:
  • Physical security and biometric access control for server/archival rooms
  • Efficient disaster recovery and business continuity planning
  • Security of clinical study data ensured by use of Firewall, and TLS encryption for emails & IPSEC for business to business secure virtual private network (VPN)

For more information email us at bd@siroclinpharm.com or contact us today.