In today’s world of evidence-based medicine, publications are the most important documents. Publications are a source of communicating the results of a trial or a study to the world or target audience. Publications give a direction for further research and are also considered an indicator of potential and current achievement. A well-written publication can enhance the importance of your data and give an edge to your product. Based on the type of data, publications may be varied-original articles (primary manuscript, secondary manuscript), case reports, brief communication or letter to editor. Be it be any publication, Knowledge Isotopes has an expertise and experience to effectively handle any of these.
Medical writers at Knowledge Isotopes work directly with authors/investigators and clients as an integrated team. This helps them understand their perspectives and gain an insight in to their objective of publishing the data. To be sure that the data that is communicated is accurate, process of internal review and data QC is followed. At every step or milestone achieved like outline stage, first draft stage etc., the draft undergoes review by all the authors. Our writer then compiles the comments and revises the draft based on those comments. A quality writing and clear communication of data brings satisfaction to our authors, clients and our writers. The articles written by Knowledge Isotopes are compliant to the relevant guidelines. All our writers undergo periodic trainings to keep themselves abreast of the various guidelines.
Meta-analysis gives the precise or closer to truth estimate of a treatment effect or a measure of interest. It is a statistical procedure but the quality depends on the kind of studies that are included in the meta-analysis. This study (data) mining requires expertise and skill. At Knowledge Isotopes, we provide our clients with a comprehensive search strategy and also help them define inclusion and exclusion criteria for the studies. We have previously conducted meta-analysis as per QUOROM and PRISMA guidelines. For some of the meta-analysis involving clinical trials, we have used JADED scoring system to score the quality of trials. Our meta-analyses have been published in International journals of repute.
Input based on experience is crucial to clinical research. Expert opinion (s) represents a form of medical knowledge complementary to evidence based medicine. Knowledge Isotopes has the valuable experience of developing expert opinions. We have supported our clients in developing expert opinion/consensus papers by providing offsite and onsite support. Smooth co-ordination and rigorous follow-up are the pre-requisite in developing expert opinions. Knowledge Isotopes specializes in writing and circulating minutes of meetings of expert panel, taking approvals from panel members, collating comments, building a consensus and finally writing the paper. Knowledge Isotopes has worked as an integral team to the expert panel and helped them ease themselves.
Presenting your data at the conferences is a quick and direct way of getting heard to your target audience. An abstract is the face of your study. Many abstracts suffer rejection due to ambiguity in writing and confusion over what to present. Knowledge Isotopes has a track record of acceptance of 100% abstracts and quick TAT for authors. At Knowledge Isotopes, we write scientific content for posters and also design them. Posters developed by Knowledge Isotopes have been presented nationally and internationally and have been awarded. We give a distinguishing edge to your poster or presentation by designing a unique template. Some of our clients have made templates designed by us as their brand or product templates.
Knowledge Isotopes is also apt at developing other documents that includes but not limited to: - Newsletters - Speaker Notes/slides - Frequently Asked Questions, Approved Responses - Standard and Customized Letters for Medical Inquiries - Standard Operating Procedures (SOPs) - Templates and style guides - Editorial Support - Submission Packages - Website content for product/brand
A poorly written CSR can jeopardize the trial. We at Knowledge Isotopes provide support for writing ICH GCP compliant Phases I to IV CSR including CSR Synopses for public disclosure.
Clinical trials conducted under an IND or IDE cannot begin without a protocol. This makes writing protocols as per the ICH guidelines important. We coordinate with the investigators, develop a basic statistical understanding (e.g., qualitative and quantitative data, sample size determination, and interim analysis) of the study and develop a protocol. We bring the therapeutic, clinical, regulatory, and writing expertise needed to ensure the success of your clinical trial from beginning to end.
Investigator Brochure is primary source of information for investigators who participating in a clinical trial. It provides the scientific and medical basis for the study drug/biologic/product or technology that is being assessed. It also needs regular updating based on the arrival of new information. The writers at Knowledge Isotopes are trained to knit the information needed for an IB in an organized manner and present it in a lucid manner.
- Patient safety narratives/ Periodic Safety Update Reports (PSURs)
- Annual Safety Reports
- Patient information sheets/ Informed Consent / Patient Brochures
We are aware of the dearth of the availability of customized training solutions for pharmaceutical people. For each training program, the agenda is made after knowing the needs and expectations of the clients. The presentations sessions are specially made and hence are unique for all trainings. In the past, we have provided trainings with excellent feedback on the niche topics that include:
- Essentials of Medical Writing
- Effective Communication Strategy: The Publication Plan
- Bio-statistics To Power your research
- Digital in Medical Affairs
- ICH-GCP and Schedule Y
- Customized Training Solutions
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