SIRO Clinpharm, winner of "Best Clinical Research Company" of the year in Healthcare and Fitness Leadership Awards 2016 organised by CMO Asia and Stars of the Industry Group and two times winner of Frost & Sullivan 'Indian Clinical Research Organization of the year' award, is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics & statistical programming & pharmacovigilance. With a successful track record of about 20 years, SIRO Clinpharm works with most of the top global biopharma & medical device companies. Our therapeutic experience includes but is not limited to oncology, diabetes, cardiology, infectious diseases & respiratory system. We offer flexible business models across service verticals based on client needs.
Skilled project management is the key to the success of any clinical trial. With an increase in the complexity of clinical trials, importance of effective project management has come to the fore. To attend to various complexities of the trial, you need a team that is not just experienced but is also innovative, flexible and nimble.
At SIRO Clinpharm, we have honed our project management expertise by conducting complex studies in varied therapeutic areas and phases across the globe. Additionally, the location of the project management team has been designed keeping in mind the needs of our clients in the key markets of North America, Europe and Asia.
Our project management team adheres to the highest standards of operational excellence and 'established industry best practices' to ensure high quality and on-time deliverables. With SOPs designed to ensure smooth communication, collaboration and project ownership, you can be rest assured that your project is in capable hands.
The Clinical Monitoring team is designed to closely work with the project management team in order to ensure that your study is executed precisely. Our team of CRAs, Sr. CRAs and team leaders are familiar with industry best practices and local regulations.
We believe that effective training assures excellence. Therefore, our clinical monitoring team is imparted with exhaustive training in local regulations, study protocols and therapeutic areas.
The geographic distribution of our team lends itself to operational flexibility and efficiency all the while keeping the clients best interests in mind.
Documentation forms an integral part of Clinical Research Industry bound by stringent rules and regulation.
With systematic filing & correct documentation processes, a well-established documentation system is one of the foundations of the functioning of clinical operations. Keeping this in mind, the Clinical Documentation department was introduced at SIRO. The documentation team is solely dedicated to ensure quality documentation in terms of local regulations, ICH-GCP compliance and standard operating procedures.
SIRO Clinpharm offers a robust 21 CFR Part 11 compliant clinical trial management system to support document tracking at global, country and site level.
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.
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.
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:
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.
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:
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.
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:
• Protocols & ICDs
• Pre-DBL Narratives
• Shell CSR with Mock Tables • Post-DBL Narratives
• CSR with Appendices
• eCTD Modules
• Summary/HA Documents
• Primary & Secondary Manuscripts
• Review Articles
• Abstracts, Posters & Slide Decks
• Training Modules
• Graphic Design Support
• Literature Review
• HTA submissions
• HE modelling
• Aggregate Reports (DSUR/
• PBRER/PSUR/PADER/SUSAR LL) • RMPs (EU/Core)
SIRO offers a comprehensive range of medical and pharmacovigilance services essential for the conduct of clinical trials including study preparation, study conduct, medical coding, medical review and Drug Safety Officer (DSO)activities. Depending on the contractual obligations, the staff at SIRO may take over a part or the complete responsibility for any medical or safety-related issues.
The medical affairs team is comprised of physicians and pharmacists with many years of medical and pharmacovigilance experience and detailed knowledge in various therapeutic areas. By this we ensure that key requirements within clinical trials are managed in line with regulatory demands. For pharmacovigilance this includes not only the expedited reporting of Suspected Unexpected Serious Adverse Reactions (SUSAR) but also the appropriate handling of Serious Adverse Events (SAE) and Unexpected Adverse Event Information. On demand SIRO can provide 24X7 backup to investigators during conduct of trials.
Within the scope of contracted services, the pharmacovigilance team at SIRO is competent to monitor safety and efficacy of investigational medicinal products and marketed drugs. We make sure reporting obligations are in line with world wide regulatory requirements and thus contribute to the ongoing risk-benefit assessment.
Our services are offered across all phases of clinical development. They ensure safetyand risk management throughout clinical development and post-approval. Our expert advisory services help sponsors identify and manage post-marketing setbacks that threaten both product revenues and reputation.
By offering this service, we are able to support pharmaceutical companies within specific functions. Our pharmacovigilance service is particularly useful for companies without a dedicated pharmacovigilance department that are looking for specific, cost-effective solutions for pharmacovigilance tasks.
Tasks handled by our pharmacovigilance team include:
The medical advisor will conduct, support, and review the development of all documents required within a clinical trial (e.g. protocol, informed consent, CRF) and prepare for approval by the sponsor. The medical advisor will assist the study team for all medical issues before, during, and after the conduct of the study.
The Drug Safety Officer (DSO) is responsible for the review of all study-related documents and the detailed safety review of all incoming CRFs within 24 hours after receipt (or at least on the next working day in the case of weekends). Previously not recognized or not appropriately reported Serious Adverse Events or Unexpected Adverse Events must be notified to the sponsor within 24 hours and documented on an initial SAE report form. If data is incomplete or inconsistent, the DSO may contact the investigator directly for clarification of those issues and document this in an SAE follow-up report.
As biopharmaceutical companies expand their operations, the various components of the trial see variations as per the local regulations and infrastructure. One of the key drivers of a safe clinical trial is the supply chain management for the drug that is being administered. Given that factors like temperature sensitivity, regulatory compliance, safety and security of the drug has huge impacts on timelines and costs of a study, sponsors and CROs have realized the need to focus on Clinical Trial Supply Management.
SIRO Clinpharm is one of the few clinical research organizations in the Indian sub-continent to offer clinical trial supplies (CTS) management services. Our fully equipped CTS facility is located in Mumbai and is well connected to all parts of the country. We offer end-to-end supply solutions, from the import of investigational product to distributing and retrieving the same from investigational sites, and finally destroying it under appropriate conditions.
From conceptualization to the final analysis and interpretation of results, biostatistics impacts a clinical study at all stages Biostatistics is one of the most crucial elements for any successful clinical trial because it produces tested, science-based answers. With the data produced by biostatistics, facts and justifiable methods are easier to come by.
Whether your project requires appropriate study design, selection of endpoints, correct analysis methods, sample size estimation, statistical programming,the ability to make sound decisions is vital to your success. Quite simply, math and science-based statistical analysis awakens that success.
SIRO Clinpharm offers:
• Statistical inputs to protocol
• Sample size estimation
• Randomization for open label and blinded studies
• SAP Development
• Supporting in DSMB activities/ Interim analysis
• Full DMC support, including preparation of the DMC charter
• PK and PD Analysis
• Statistical Analysis of trial data
• Interpretation of results and input to Clinical Study Reports
As an international full service CRO, SIRO Clinpharmenables you to make befitting decisions regarding these crucial aspects by providing the full scope of statistical and programming services. Some of these services include:
Consult with our experts on the proper way to plan and implement CDISC conversion leading up to a submission. Here is a brief overview of our CDISC standards services
Marketing, Communication & Graphic Design Services
Business Operations and Logistics Support Services
Business Development & Support Services
Epidemiology, HEOR, and Post-Authorization Studies Services
Biostatistics & Bioinformatics Services
Software Development and IT Services
Clinical Trials, Consulting, and Management Services
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