Medical Writing
Why should you employ a Specialist Medical Writer from Medical KPO?
What abilities does a medical writer bring to the table?
What makes Medical KPO's Medical Writers so unique?
Can't statisticians, clinicians, or investigators write my documents?
How will my clinical team participate in the document's creation and review?
How can I determine precisely what I require?
Where can I find Medical KPO's Medical Writers?
Documents
Medical KPO creates what kinds of documents?
Medical KPO prepares papers in which format?
Experience
What makes up a Medical KPO devoted team?
Do Medical KPO papers adhere to ICH and GCP guidelines?
Do Medical KPO's communications papers adhere to the ABPI Code of Conduct?
What information must the client provide?
Medical KPO's document creation formats and style standards are as follows.
Is it possible to request if my own style guide or documentation templates be used?
Training
What kind of medical writing training does Medical KPO have?
How are Medical KPO staff trained?
Outsourcing
Could I delegate all of my medical writing needs to Medical KPO?
How do you start?
How do you work?
Getting Started
Can I afford Medical KPO's expert medical writing services?
How can I start the process?
Medical Writing
Why should you employ a Specialist Medical Writer from Medical KPO?
A medical writer from Medical KPO will assist your healthcare organization in two ways: first, by preparing a grant proposal or application for financing, and second, by compiling all of the material into a quarterly/annual report to track progress.
What abilities does a medical writer bring to the table?
Medical KPO writers like and excel in both science and literature. They also comprehend medical concepts and ideas and can provide data and its interpretation in a way that the target audience would understand. The best medical writing abilities are domain expertise, ynderstanding your target audience, writing abilities, data consistency, maintaining your knowledge, clarity, review of literature and a unique perspective.
What makes Medical KPO's Medical Writers so unique?
A professional medical writer at Medical KPO is someone who understands medical, scientific, and health jargon and concepts as well as the ability to interpret such material into a variety of formats for various audiences. Medical writers come from a range of backgrounds and can work in a variety of settings.
Can't statisticians, clinicians, or investigators write my documents?
In our experience, no. The interpretation and presentation of results is a talent in and of itself. Medical writing is not often considered when selecting the finest statistician, clinician, or investigator – and the burden of doing so might be an unwelcome distraction and bottleneck for the clinical team. When a qualified medical writer is involved, the finest papers are generally produced — to manage the input process, prepare the documentation, and assure its efficient and effective evaluation.
How will my clinical team participate in the document's creation and review?
Medical KPO's Lead Writer will oversee all parts of the input, production, and evaluation for your project. A checklist of essential inputs, a skeletal document architecture, and a "kick-off" meeting marks the start of document creation, which can begin even before the data is ready to optimize timeframes. A controlled review method, improved over hundreds of projects, results in rapid, effective, and efficient review - without undue stress or effort from clinical professionals, but yet challenging your experts to crystallize their primary ideas. Kick-off and review meetings are occasionally held in the client's location, but the geographical spread of the clinical team members sometimes necessitates "virtual team" working — based on phone conferences, email, and other contacts.
How can I determine precisely what I require?
Medical KPO is prepared to assist you in assessing any of your requirements. Medical KPO will offer you checklists and project life cycle plans before scheduling a strategy meeting to address your documentation and timetable requirements. We will offer you an assessment of your existing requirements and a strategy for going forward based on your comments and conversation. Please do not be hesitant to question us: Some of our clients are organizations that grew from the development of a single compound and do not yet have expertise in drafting or submitting regulatory paperwork and are unaware of all the documentation required. Even for existing clients, the shifting regulatory requirements (e.g., requesting new types of paperwork for newly regulated fields such as pediatrics, health economics, benefits statements, and so on) can be difficult to keep up with. It may be perplexing to determine which means of communication and which message, in particular, will work best for your therapy and reach your target audience most successfully, whether in the pre- or post-approval phase. Please contact us and provide a brief explanation of your problem.
Where can I find Medical KPO's Medical Writers?
Our medical writers are found in Europe and the Philippines and are used to traveling around the world and directing worldwide "virtual teams" of clinical development team members from all around the world.
Documents
Medical KPO creates what kinds of documents?
Medical KPO creates any form of documentation that is required, either for your regulatory programs, such as: Books for Briefing, CDP (Clinical Development Plan), CSP (Clinical Study Protocol), CSR (Clinical Study Report), CTD (Common Technical Document), CTR (Clinical Trial Report), DSUR (Development Safety Update Report), and IB (Investigator's Brochure) are acronyms for Clinical Development Plan, CSP (Clinical Study Protocol), CTR (Clinical Trial Report PADER (Periodic Adverse Drug Experience Report), PI (Product Information), PIP (Paediatric Investigation Plan), PPP (Pregnancy Prevention Plan), PSP (Pediatric Study Plan), PSUR (Periodic Safety Update Report), REMS (Risk Evaluation and Mitigation Strategies), RMP (Risk Management Plan), SAP (Statistical Analysis Plan), SmPC (Summary of Product Characteristics), SmPC (Summary of Product Characteristics) (United States Prescribing Information). We also work in support of your other communication requirements, such as abstracts, papers, posters, and slide sets.
Medical KPO prepares papers in which format?
Medical KPO creates English papers in Microsoft Office (Word, Excel, PowerPoint) and/or PDF formats, suitable for inclusion in your submission dossier.
Experience
What makes up a Medical KPO devoted team?
Each Medical KPO specialized medical writing team is made up of medical writers, project managers, and quality control specialists that work together to assure the timely and optimum creation of our clients' clinical documentation. Each team has a team leader who oversees each document and serves as the client's principal point of contact.
Do Medical KPO papers adhere to ICH and GCP guidelines?
Yes. Our Clinical Study Reports (CSRs) adhere to the International Conference on Harmonisation (ICH) E3 guidelines, while our Common Technical Document (CTD) submissions adhere to the ICH M4 guidelines. We designed our documentation process to be in accordance with Good Clinical Practice (GCP), and we include GCP and Continuing Professional Development (CPD) concepts into all of our work.
Do Medical KPO's communications papers adhere to the ABPI Code of Conduct?
Yes. We can guarantee that all of your scientific communications paperwork complies not just with the ABPI Code, but also with any other applicable codes (for example, EFPIA).
What information must the client provide?
Our clients provide the relevant documentation and data needed to prepare the specific document being written. Our clients also provide review inputs on each draft produced and are responsible for ensuring that the medical content and messages concur with their company’s policies.
Medical KPO's document creation formats and style standards are as follows.
To guarantee uniform authoring, we prepare all of our publications using standard Microsoft Office software and style standards (e.g. Word, Excel, PowerPoint etc.). The Medical KPO style guide represents our in-depth knowledge and expertise with clinical documentation. We may, of course, utilize your company's own style guidelines and/or templates if you want.
Is it possible to request if my own style guide or documentation templates be used?
Yes. We can use your pre-made document templates and/or style guidelines as needed, or we can assist you in developing your own internal house style.
Training
What kind of medical writing training does Medical KPO have?
We are trained in medical writing foundation skills, specific clinical documentation and strategic communication capabilities.
How are Medical KPO staff trained?
Our staff undergo training courses targeted to their unique needs that cover a wide range of clinical documents, including new requirements and changes in practices as needed for Continuing Professional Development (CPD).
Outsourcing
Could I delegate all of my medical writing needs to Medical KPO?
Yes. Medical KPO's objective is to engage with our clients proactively to manage and develop their whole clinical documentation. By involving us early on, you can be assured of proactive assistance in initiating the necessary documents, planned availability and continuity of medical writers, and coordination of your clinical team throughout the production and review process.
How do you start?
We begin by developing the protocols for the initial studies and work with our customers to write all subsequent research protocols and reports, culminating in the development of submission dossiers in the Common Technical Document (CTD) format.
How do you work?
Clients frequently want to take advantage of our knowledge with their development program by having us produce articles and scientific publications based on the research reports we created. A specialized Medical KPO writing team integrated inside our client's clinical development team provides the highest standards, as well as maximum consistency and continuity. Our teams have served as "glue" inside development teams, bringing together disparate clinical team roles through documentation, and have served as catalysts in distilling the important messages by constructively questioning the clinical team throughout the process. This can be a significant benefit in integrating an outsourced clinical development team, especially when it spans many organizations and regions.
Getting Started
Can I afford Medical KPO's expert medical writing services?
Our prices are very affordable compared to most clinical research organizations and freelance medical writers. You can pay via credit card and via installments. Attention to solid documentation is a minor price to pay to guarantee your clinical research product has the highest chance of regulatory success. A well-written protocol or research report is not too tiny for any investigation. We are pleased to offer you a cost estimate for your project and can usually do so within a few days after obtaining specific data about your needs. Our prices are very affordable compared to most clinical research organizations and freelance medical writers. You can pay via credit card and via installments.
How can I start the process?
Please contact us to discuss your specific needs. We are pleased to give you a cost estimate and project plan for your project, no matter how large or little, within a few days after obtaining specific data about your needs.
