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Medical Writing services

Bioforum offers premium medical writing services across all therapeutic areas and fields within biomedical sciences. All of our writing experts hold doctorates, and have many years of writing experience.
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We write clear, accurate and regulation-compliant documents, and deliver them on time.
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    Regulatory Documents Medical Communication Complementary Services

    Regulatory Medical Documents

    Bioforum offers premium medical writing services across all therapeutic areas and fields within biomedical sciences. All of our writing experts hold doctorates and have many years of writing experience. Documentation styles include study-specific and development program documents. The medical writing service is fully integrated into multi-disciplinary clinical development teams, specifically safety, biostatistics and data management, aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines.

    Writing support for clinical studies
    • Clinical study protocols and clinical study reports
    • Patient narratives

    Writing support for full product development programs
    • Briefing packages for meetings with regulators
    • Data safety update reports
    • Investigator brochures
    • Common Technical Document (CTD) summaries

    Clinical writer – Study Protocols

    Our experienced team of medical writers supports clinical development teams in creating clinical study protocols. As soon as the design has been decided, the medical writer develops it into a full, submission-ready and ICH E6-compliant document. The Bioforum medical writer becomes a part of the clinical development team, taking care to receive input from all relevant study stakeholders. We keep a flexible and agile approach, assisting teams in creating protocols that reflect the most up-to-date decisions in the complex process of study design.

    Clinical Study Reports and Summaries

    Bioforum writers have vast experience in writing clinical study reports and CTD summaries in a wide array of therapeutic areas. We write reports that are ICH E3-compliant (or ISO 14155 for medical device, as applicable) for studies from Phase I (including clinical pharmacology studies), through Phase II and III (clinical efficacy and safety) to Phase IV (including safety registry and post-marketing observational studies). We have experience in writing the Module 2.7.1 Summary of Biopharmaceutic Studies, Module 2.7.2 Summary of Clinical Pharmacology, Module 2.7.3 Summary of Clinical Efficacy and Module 2.7.4 Summary of Clinical Safety, as well as reports of integrated analyses (Module 5.3.5.3 Integrated Summary of Efficacy and Integrated Summary of Safety) and clinical overviews. We work in collaboration with the clinical, regulatory and statistical experts to develop the most accurate and clear reports and summaries, paying meticulous attention to detail while taking care to provide the reader with a holistic understanding of results.

     

    Journal Articles

    Bioforum medical writers provide tailored support for journal article writing. The level of support is determined based on client needs and can range from de novo writing of articles from source materials (such as clinical study reports or statistical analysis reports) to light editing of drafts prepared by the clients.

    Articles are edited to meet specific journal requirements and to adhere to the highest writing and ethics standards and to reporting guidelines.

    Bioforum writers also offer support for addressing reviewers’ comments and revisions prior to re-submission.

    Medical Communication Strategy

    Bioforum medical writers can assist in identifying potential target journals, suitable to the article’s content and structure, as well as the Sponsor’s publishing goals.

    Presentations and Posters

    Medical communication support also encompasses writing and editing text for medical presentation slide decks and meeting abstract and poster presentations.

    QC support for regulatory documents

    Bioforum QC associates provide thorough quality checking of regulatory documents written by Bioforum medical writers, as well as documents written by authors outside of Bioforum. Quality checking is performed based either on Bioforum’s checklist or the client’s.

    Regulatory document publishing & eCTD services

    • Bioforum provides publishing and editing services of PDF documents according to ICH and national regulatory authority guidelines.
    • Manages documents and eCTD sequence lifecycles in a dedicated document management system in accordance with regulatory requirements.
    • Creates and publishes eCTD sequences in a dedicated eCTD compilation system in accordance with regulatory requirements.
    • Validates eCTD sequences using specialized validation tools in accordance with ICH and national regulatory authority validation criteria.
    • Submits eCTD sequences to regulatory agencies.

    Training Sessions

    Our medical writers offer training sessions tailored to customer needs, on various writing-related topics.

    Examples include:
    • A full-day training program for physician-researchers
    • A full-day course on regulatory clinical documents
    • A half-day session on protocol development

    Our Expertise

    Doctorate-level education with many years of experience
    Wide range of therapeutic areas
    Early and late phase product development

    Meet our team

    Our Medical Writing team, led by Shiri Diskin, can assist you over a wide range of therapeutic areas and can provide you with clear documents that will support your research from start to finish.

    Shiri holds a PhD in cell, molecular and developmental biology from Tufts University, USA. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Since then, she has been working as an independent instructor and consultant of medical writing. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines. In addition to regulatory documents, Shiri is an expert in writing scientific journal articles. She writes and edits manuscripts, and teaches workshops to medical doctors and scientists on this subject. Her book on the subject has recently been published worldwide.
    My name is Andriana Papaconstantinou. I hold a PhD in biology and an MSc in toxicology from George Washington University, USA. I worked as a medical writer in a US-based CRO for 2 years and in a Greece-based CRO for nearly 9 years before joining Bioforum in 2021. I am an expert in authoring protocols, CSRs and scientific journal articles. After all these years, my enthusiasm for being in this profession continues to grow. I love how the work itself is very structured and organized, but the topics are ever-changing. There is an opportunity to learn something every day by writing new types of documents, getting involved in projects with novel medications or diseases outside of my areas of expertise, but also through trying to keep abreast of all the changes in the regulations underpinning clinical trials. Bioforum’s strength lies within its team, the flexibility given to people to be employees without compromising their personal lives, the eagerness of the team members to do their best each day, the opportunities the team is given for development through internal training and support, and the team’s diversity. At Bioforum, I feel I can do what I love with people that like to be well-prepared and show deep passion for their work and strong togetherness.
    My name is Cheryl Berkowitz. I hold a PhD in molecular virology from the Hebrew University of Jerusalem, Israel. My professional career as a scientific writer and editor has taken me through academic writing, writing and prosecuting patents, through to the pharma industry, in which I have wide-ranging experience in the preparation of global regulatory submission documents (CTDs), particularly CMC documentation. I have always enjoyed the writing process, working and molding a document to bring it to the highest possible level of precision and clarity. In addition, I am perpetually curious about the world of biology and specifically, new advances in the field of biomedical sciences. Medical writing to me brings together in one package everything that I find exciting and enjoy doing. The medical writers at Bioforum are a diverse group of people, brought together by a common love of organizing vast amounts of data into coherent and cohesive documents for the client. The desire to share knowledge and provide mutual support are what makes the Bioforum MW team so special and successful.
    My name is Dana Savulescu. I hold a PhD in molecular and cell biology from the Technion – Israel Institute of Technology, and a post-doctorate in immunology and infectious diseases from the University of the Witwatersrand, South Africa. I have over 15 years of experience in research, including in molecular and cell biology, oncology, molecular endocrinology, immunology and infectious diseases. Since joining Bioforum as a Medical Writer, I have been involved in the preparation of regulatory and medical documents, scientific manuscripts and lay language summaries, in various scientific domains, including oncology, Covid-19, pharmacology, ADHD and more. I enjoy all aspects of medical writing, especially the process of integrating large amounts of information into regulatory documents, and the opportunity to learn the clinical background of each project in which I am involved. I am grateful for the opportunity to be involved in the process of turning an investigational product into a drug used in practice to treat patients.
    My name is Daniela Kamir. I hold a PhD in molecular biology. I received my professional training at the RWTH Aachen University (Germany), Yale University (USA) and The Jackson Laboratory (USA). In the past, I held positions including researcher, lab head and NGS/variant analyst. My areas of expertise are in the fields of medical devices, molecular biology, genomics and applied bioinformatics, to which I was first exposed during my postdoctoral training. Since joining Bioforum as a Medical Writer, I have written scientific and clinical articles, clinical study protocols, clinical study reports, narratives, summaries of clinical safety and marketing requirement documents for the pharmaceutical and medical device sector. An essential part of Medical Writing is presenting the veracity and relevancy of data in a coherent manner, keeping up with new practices, getting answers to key questions, staying up to date with the never-ending advancements of science and medicine, and working on a variety of topics and medical problems.
    My name is Danielle Hadar. I hold a BSc in life sciences from Bar-Ilan University, Israel. I enjoy the process of quality checking, learning about every new document that comes my way, figuring out what it is about and whether it is presented accurately and precisely, going through it thoroughly to find any mistakes, and then bringing the document to the highest technical level for our clients. Working in Bioforum with a team of knowledgeable people who care deeply about their work is fantastic. Together we create a great work environment for any client and produce documents of the highest standards ready for submission.
    My name is Dionne Crafford. I hold a PhD in zoology (specializing in parasitology) from the University of Johannesburg, South Africa. I have been a researcher, investigator and scientific writer in the animal health industry (contract research organization GCP/GLP environment) for more than 20 years, working predominantly in the field of target animal anthelmintic efficacy (companion and domestic/farm animals). I shifted to Medical Writing when I moved to Bioforum. I love the challenges associated with this vast field. The profession inherently requires continuous knowledge acquisition, resulting in both professional and personal growth. The employee-oriented environment at Bioforum immediately impressed me, providing a professional yet friendly and supportive environment in which to grow and excel.
    My name is Fadwa Dabbah. I hold a PhD in medical research from the Technion – Israel Institute of Technology, Israel. My thesis studies focused on molecular neurodevelopmental and behavioral science. My focus areas are mainly pharmaceuticals and biologicals. Medical writing represents the realization and outcome of a scientific research process. Only through clear, high-level writing can research be translated properly to accredited clinical practice for the benefit of the patient and the community of scholars. Bioforum is a rapidly growing global CRO. Our MW department is a team of highly educated professionals. We love to cooperate and work as a team. The quality we offer in medical writing guarantees a pioneering service that provides client satisfaction.
    My name is Liat Laufer. I hold a BSc in life sciences and a Doctor of Veterinary Medicine (DVM), both from the Hebrew University of Jerusalem, Israel. My main area of expertise and point of interest is medical devices. What I love most about medical writing is the need and the ability to integrate a lot of information and data, in a coherent and rational manner. You must be capable of constantly learning new information up to a certain level that allows you to develop ideas, draw conclusions and convey a message. It must be written in a way which will appeal not only the customer, but also to the audience you are aiming for, and their point of view. In addition, the written product needs to be presented in line with the latest regulatory requirements. It requires you, as a writer, to know the latest updated regulatory requirements very well, where it is more flexible, and has less importance for gaining market approval, and where it is more imperative and stringent. As a service provider, it requires you to create a fine balance between the customer needs and limited customer resources on one hand, and the changing regulatory requirements, which are becoming stricter, on the other hand. Bioforum has the best combination of professional excellence, along with great people who make teamwork productive and fun and encourages employees to provide high quality work.
    My name is Luba Binshtok. I hold a PhD in cognitive sciences from the Hebrew University of Jerusalem, Israel. My academic background is in neurocognitive human research. As a medical writer, my areas of expertise are pharmaceuticals and biologicals associated with a wide spectrum of clinical fields, including neuro-degenerative diseases, oncology, respiratory diseases, orthopedics, neonatal health, pediatrics, diabetes, nephrology and more. One of the most amazing human abilities is the ability to formulate ideas and thoughts into coherent language that can accurately communicate these thoughts and ideas to others. We all can appreciate the experience of reading/perceiving clearly expressed thoughts. I believe that this ability is fundamentally important in research in general and in clinical research specifically, in order to make good science and achieve substantial progress. When a big set of data is received and, slowly, a coherent story is formed and the results become clear – I think it is an amazing process and I feel privileged to be able to contribute.
    My name is Marisa Moller-Wolmarans. I hold a PhD in pharmacology from the North-West University, South Africa, with a specific focus on neuropsychiatric diseases. I have more than 13 years of experience in preclinical as well as clinical pharmacological research in the areas of neuropsychiatric and cardiovascular diseases. Specifically, my preclinical research evaluated psychopharmacology in animal models, while my clinical research evaluated neuropsychiatric (schizophrenia, depression and addictive disorders) and cardiovascular (hypertension and coronary artery disease) disease treatment as well as the development of analytical methods. My passion for medical writing developed from a significant interest in pharmacology and the ability to simplify and organize complex medical mechanisms, concepts, methods, findings and outcomes or results in such a manner that it appeals to the specific audience to which it is aimed.
    My name is Marshalle Peleg. I hold a BSc in family science and kinesiology and a BA in stage management from the University of Maryland, USA. We help clients get their documents to regulatory authorities appropriately and on time. I love working in such a collaborative environment with a team of experts. Everyone at Bioforum is so warm and generous and willing to share their knowledge so we can all succeed together.
    My name is Rumiana Petronva. My PhD is in cancer biology and anti-cancer therapeutics from the University of Haifa, Israel. My areas of expertise are in oncology, hematology, cardiology, and bone diseases, with experience in clinical and observational studies and patient support programs. I am honored to be part of a team of passionate and talented medical writers who put their full effort into every piece they write.
    Shiri holds a PhD in cell, molecular and developmental biology from Tufts University, USA. She has been a medical writer since 2009. Shiri worked as a medical writer and medical writing team leader at Teva until 2014. Since then, she has been working as an independent instructor and consultant of medical writing. Shiri is experienced in managing medical writing projects of early and late phase product development. Her expertise encompasses study-specific documents such as protocols and clinical study reports, as well as development-program documents such as investigator’s brochures and summaries of efficacy and safety. Shiri is experienced in close collaboration with multi-disciplinary clinical development teams, specifically safety, biostatistics and data management aimed at producing the highest-quality, most regulation-compliant, clear and informative documents while adhering to timelines. In addition to regulatory documents, Shiri is an expert in writing scientific journal articles. She writes and edits manuscripts, and teaches workshops to medical doctors and scientists on this subject. Her book on the subject has recently been published worldwide.
    My name is Andriana Papaconstantinou. I hold a PhD in biology and an MSc in toxicology from George Washington University, USA. I worked as a medical writer in a US-based CRO for 2 years and in a Greece-based CRO for nearly 9 years before joining Bioforum in 2021. I am an expert in authoring protocols, CSRs and scientific journal articles. After all these years, my enthusiasm for being in this profession continues to grow. I love how the work itself is very structured and organized, but the topics are ever-changing. There is an opportunity to learn something every day by writing new types of documents, getting involved in projects with novel medications or diseases outside of my areas of expertise, but also through trying to keep abreast of all the changes in the regulations underpinning clinical trials. Bioforum’s strength lies within its team, the flexibility given to people to be employees without compromising their personal lives, the eagerness of the team members to do their best each day, the opportunities the team is given for development through internal training and support, and the team’s diversity. At Bioforum, I feel I can do what I love with people that like to be well-prepared and show deep passion for their work and strong togetherness.
    My name is Cheryl Berkowitz. I hold a PhD in molecular virology from the Hebrew University of Jerusalem, Israel. My professional career as a scientific writer and editor has taken me through academic writing, writing and prosecuting patents, through to the pharma industry, in which I have wide-ranging experience in the preparation of global regulatory submission documents (CTDs), particularly CMC documentation. I have always enjoyed the writing process, working and molding a document to bring it to the highest possible level of precision and clarity. In addition, I am perpetually curious about the world of biology and specifically, new advances in the field of biomedical sciences. Medical writing to me brings together in one package everything that I find exciting and enjoy doing. The medical writers at Bioforum are a diverse group of people, brought together by a common love of organizing vast amounts of data into coherent and cohesive documents for the client. The desire to share knowledge and provide mutual support are what makes the Bioforum MW team so special and successful.
    My name is Dana Savulescu. I hold a PhD in molecular and cell biology from the Technion – Israel Institute of Technology, and a post-doctorate in immunology and infectious diseases from the University of the Witwatersrand, South Africa. I have over 15 years of experience in research, including in molecular and cell biology, oncology, molecular endocrinology, immunology and infectious diseases. Since joining Bioforum as a Medical Writer, I have been involved in the preparation of regulatory and medical documents, scientific manuscripts and lay language summaries, in various scientific domains, including oncology, Covid-19, pharmacology, ADHD and more. I enjoy all aspects of medical writing, especially the process of integrating large amounts of information into regulatory documents, and the opportunity to learn the clinical background of each project in which I am involved. I am grateful for the opportunity to be involved in the process of turning an investigational product into a drug used in practice to treat patients.
    My name is Daniela Kamir. I hold a PhD in molecular biology. I received my professional training at the RWTH Aachen University (Germany), Yale University (USA) and The Jackson Laboratory (USA). In the past, I held positions including researcher, lab head and NGS/variant analyst. My areas of expertise are in the fields of medical devices, molecular biology, genomics and applied bioinformatics, to which I was first exposed during my postdoctoral training. Since joining Bioforum as a Medical Writer, I have written scientific and clinical articles, clinical study protocols, clinical study reports, narratives, summaries of clinical safety and marketing requirement documents for the pharmaceutical and medical device sector. An essential part of Medical Writing is presenting the veracity and relevancy of data in a coherent manner, keeping up with new practices, getting answers to key questions, staying up to date with the never-ending advancements of science and medicine, and working on a variety of topics and medical problems.
    My name is Danielle Hadar. I hold a BSc in life sciences from Bar-Ilan University, Israel. I enjoy the process of quality checking, learning about every new document that comes my way, figuring out what it is about and whether it is presented accurately and precisely, going through it thoroughly to find any mistakes, and then bringing the document to the highest technical level for our clients. Working in Bioforum with a team of knowledgeable people who care deeply about their work is fantastic. Together we create a great work environment for any client and produce documents of the highest standards ready for submission.
    My name is Dionne Crafford. I hold a PhD in zoology (specializing in parasitology) from the University of Johannesburg, South Africa. I have been a researcher, investigator and scientific writer in the animal health industry (contract research organization GCP/GLP environment) for more than 20 years, working predominantly in the field of target animal anthelmintic efficacy (companion and domestic/farm animals). I shifted to Medical Writing when I moved to Bioforum. I love the challenges associated with this vast field. The profession inherently requires continuous knowledge acquisition, resulting in both professional and personal growth. The employee-oriented environment at Bioforum immediately impressed me, providing a professional yet friendly and supportive environment in which to grow and excel.
    My name is Fadwa Dabbah. I hold a PhD in medical research from the Technion – Israel Institute of Technology, Israel. My thesis studies focused on molecular neurodevelopmental and behavioral science. My focus areas are mainly pharmaceuticals and biologicals. Medical writing represents the realization and outcome of a scientific research process. Only through clear, high-level writing can research be translated properly to accredited clinical practice for the benefit of the patient and the community of scholars. Bioforum is a rapidly growing global CRO. Our MW department is a team of highly educated professionals. We love to cooperate and work as a team. The quality we offer in medical writing guarantees a pioneering service that provides client satisfaction.
    My name is Liat Laufer. I hold a BSc in life sciences and a Doctor of Veterinary Medicine (DVM), both from the Hebrew University of Jerusalem, Israel. My main area of expertise and point of interest is medical devices. What I love most about medical writing is the need and the ability to integrate a lot of information and data, in a coherent and rational manner. You must be capable of constantly learning new information up to a certain level that allows you to develop ideas, draw conclusions and convey a message. It must be written in a way which will appeal not only the customer, but also to the audience you are aiming for, and their point of view. In addition, the written product needs to be presented in line with the latest regulatory requirements. It requires you, as a writer, to know the latest updated regulatory requirements very well, where it is more flexible, and has less importance for gaining market approval, and where it is more imperative and stringent. As a service provider, it requires you to create a fine balance between the customer needs and limited customer resources on one hand, and the changing regulatory requirements, which are becoming stricter, on the other hand. Bioforum has the best combination of professional excellence, along with great people who make teamwork productive and fun and encourages employees to provide high quality work.
    My name is Luba Binshtok. I hold a PhD in cognitive sciences from the Hebrew University of Jerusalem, Israel. My academic background is in neurocognitive human research. As a medical writer, my areas of expertise are pharmaceuticals and biologicals associated with a wide spectrum of clinical fields, including neuro-degenerative diseases, oncology, respiratory diseases, orthopedics, neonatal health, pediatrics, diabetes, nephrology and more. One of the most amazing human abilities is the ability to formulate ideas and thoughts into coherent language that can accurately communicate these thoughts and ideas to others. We all can appreciate the experience of reading/perceiving clearly expressed thoughts. I believe that this ability is fundamentally important in research in general and in clinical research specifically, in order to make good science and achieve substantial progress. When a big set of data is received and, slowly, a coherent story is formed and the results become clear – I think it is an amazing process and I feel privileged to be able to contribute.
    My name is Marisa Moller-Wolmarans. I hold a PhD in pharmacology from the North-West University, South Africa, with a specific focus on neuropsychiatric diseases. I have more than 13 years of experience in preclinical as well as clinical pharmacological research in the areas of neuropsychiatric and cardiovascular diseases. Specifically, my preclinical research evaluated psychopharmacology in animal models, while my clinical research evaluated neuropsychiatric (schizophrenia, depression and addictive disorders) and cardiovascular (hypertension and coronary artery disease) disease treatment as well as the development of analytical methods. My passion for medical writing developed from a significant interest in pharmacology and the ability to simplify and organize complex medical mechanisms, concepts, methods, findings and outcomes or results in such a manner that it appeals to the specific audience to which it is aimed.
    My name is Marshalle Peleg. I hold a BSc in family science and kinesiology and a BA in stage management from the University of Maryland, USA. We help clients get their documents to regulatory authorities appropriately and on time. I love working in such a collaborative environment with a team of experts. Everyone at Bioforum is so warm and generous and willing to share their knowledge so we can all succeed together.
    My name is Rumiana Petronva. My PhD is in cancer biology and anti-cancer therapeutics from the University of Haifa, Israel. My areas of expertise are in oncology, hematology, cardiology, and bone diseases, with experience in clinical and observational studies and patient support programs. I am honored to be part of a team of passionate and talented medical writers who put their full effort into every piece they write.
    Frequently Asked Questions

    Our medical writers have experience in a wide variety of therapeutic areas including Neurology, Oncology, Infectious Diseases, Immunology, Genetics, Computational Biology/Bioinformatics, Pharmacology, Hematology, Drug Development, (AI-based) Medical Devices and Molecular Diagnostics.

    The amount of time to complete a writing project varies significantly between projects. The complexity of the studies and the development program are the primary factors in determining the time to completion of a writing project. A few additional factors are the amount of literature searching that is required (i.e., if the Sponsor can provide a literature collection, this would be a good way to accelerate the writing process), the clarity of messaging (i.e., the clearer we are on expectations at the outset, the faster we can write) and availability of reviewers to provide input on the delivered drafts. We discuss the timeline in the kickoff meeting and assign two writers per project, to increase writer availability and allow for concurrent work, where applicable.

    We prepare a unique proposal for each project. Our unit of pricing is hour of work and our basic process comprises a shell document, three full drafts, quality checking and publishing. The effort estimation includes internal review and oversight by a team leader. We also offer a timed contract model, in which a writer is fully dedicated to a client and can work on multiple projects. This model is offered on a full- or half-time employee (FTE) basis, for 3-, 6- or 12-month contracts. This model also includes support from MW team leaders.

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