Most Service Providers Devote A Significant Portion Of Their Time And Resources To Doing Medical Studies. We Also Gave It Our All
In addition to our excellent medical studies and differing viewpoints, we also have different emotions about your project.
A clinical research organization (CRO) partner that is engaged at every level is essential when facing the complex challenges of turning scientific discovery into an effective medication and then delivering that medicine into the hands of patients.
A group of individuals who are as dedicated to problem-solving, improvement, and optimization as you are.
If it takes a long time to get anything done, don't give up.
Clinical Trials Support
We do medical studies as soon as possible in order to provide innovative cures to individuals who need them as quickly as feasible. At every step of the development process, we put our hearts and souls into making the greatest positive impact possible.
We've learned a thing or two over the years about how to negotiate the world of development and approval. We are able to do this because of our experience in regulatory planning, compliance, and strategic collaborations with many organizations. With your help, we'll figure out what you need to do better and provide you with the resources you need to get there.
We can tailor an outsourcing approach to meet your specific needs, whether it's for a single clinical trial component or a broad range of medical studies and projects.
Medical Information Exchange
Medical KPO's medical communications services are backed by more than three decades of knowledge and help guarantee that your goods benefit from data that is clearly communicated and communications that are excellent.
Aspiring to be at the forefront of changing the way medicines are produced and provided to patients, Medical KPO's innovation engine.
The Medical Studies of Real-World Data
Regulatory clearance is just the beginning of the drug development process in today's environment, not the end. So, we provide medical studies with a tailored strategy to assist you to acquire the data and insights you need, not simply gigabytes of data to demonstrate value for payers, providers, and patients.
Medical KPO has the scientific competence and industry experience to deliver the complete spectrum of writing and coordinating services your trial program needs. Among our services are:
- Throughout the lifespan of your product, you must communicate essential concepts consistently and cohesively.
- In document preparation, industry best practices and standards are used.
- Processes that are efficient and fulfill tight deadlines.
- Quality control is performed on an ongoing and thorough basis.
- Management of your whole documentation cycle.
The portfolio and skills may be adjusted to your requirements, whether you want us to function as your outsourced medical writing department or write single papers when your internal medical writing staff is overworked.
Clinical Study Protocol (CSP)
- CSPs that are well-written are critical to the success of clinical investigations.
- Medical KPO collaborates closely with its customers to create CSPs that offer investigative teams logical, consistent, and unambiguous directions.
- We also produce documentation that goes along with CSPs, such as IBs, ICFs, IMPDs/INDs, etc.
- Because of the strong basis of the CSPs we create, Medical KPO is often requested to write the matching CSRs after the studies are done.
Investigational New Drug (IND)
- IND applications serve as the foundation for clinical study approval by relevant regulatory bodies in the United States. The equivalent in the European Union is known as Investigational Medicinal Product Dossiers (IMPDs).
- Having a dedicated Medical KPO team prepare not only the initial trial applications but also subsequent trial documentation (e.g., protocols, Informed Consent Forms, Investigator’s Brochures, study reports, subject narratives, Risk Management Plans, Periodic Safety Update Reports, and so on) ensures consistency and continuity, making the overall writing process more efficient and the conclusions more clear.
Informed Consent Form (ICF)
- Clear and simple ICFs outlining facts about a clinical study and its conduct are a vital step in obtaining written agreement from the patient to participate in the experiment.
- A well-prepared ICF is brief and to the point, but it must include all of the trial’s primary design elements and personal ramifications, resulting in clear legal and ethical agreements between the patient and the clinical team.
- The clarity and straightforward language used by Medical KPO ensure that the patient understands what is included in the proposed clinical study, ensuring that crucial information is provided when they agree to participate.
- Our vast knowledge of clinical trials, together with our fair and objective explanation of advantages and dangers in ordinary words, helps to guarantee that the patient is as fully informed as possible about the study.
Clinical Study Report (CSR)
- SRs are the primary way through which regulators evaluate the outcomes of clinical trials. ICH E3 specifies its format and content.
- CSRs also contain Clinical Trial Reports, which are the new EU nomenclature for CSRs when the research report is about an interventional (rather than a non-interventional) clinical trial.
- Medical KPO’s extensive expertise in producing hundreds of CSRs at all stages of clinical development and across most indications assists our customers in crystallizing the critical findings that regulators need.
- We collaborate closely with customers to solve the difficulty of writing a huge number of complicated topic narratives for CSRs.
- Our CSRs optimize and speed the preparation of subsequent CTDs.
Investigator’s Brochure (IB)
- IBS is a sophisticated paper that offers a wide picture of a product’s development to investigators and ethical committees.
- Medical KPO has years of expertise assisting customers in creating short and well-structured IBs.
- Because we understand clinical development and its tight timeframes, we can assist customers in planning and producing IBs in a timely way to support their ongoing clinical programs.
- A well-written IB that includes just the material required at the present stage of development saves time on all fronts – both for assessment by investigators and ethical committees and for preparing future updates.
Common Technical Document (CTD)
- CTDs are the application dossiers necessary for registering new medicines in Europe, the United States, and Japan and are the final result of the clinical development process; they are the greatest difficulty in clinical documentation authoring.
- ICH M4 specifies the format and content of CTDs. The CTD Summary (Module 2, sections 2.5 and 2.7) in particular provides a considerable burden to a medical writer in summarising all parts of a clinical development program, sufficient for the reviewer to swiftly identify the most important findings of the cumulative dataset.
- Medical KPO has prepared hundreds of CTD submissions, ranging from simple local variants to complicated global submission dossiers for various indications.
- Medical KPO’s proactive engagement in ensuring that all components of the clinical development program are adequately synthesized in a reviewer-friendly way is valued by our customers.
- Medical KPO achieves timelines, which is critical for successful and speedy medication approvals.
- In partnership with a strategic partner, Medical KPO may deliver eCTD-compliant dossiers.
- Clinical research programs need a wide variety of documentation, both regulatory and non-regulatory, which Medical KPO can offer.
- Having Medical KPO writers involved (e.g., preparing Clinical Development Plans, International Medicinal Product Dossiers, or Investigational New Drug applications) ensures that thoughts and messages are structured and presented from the start, which streamlines the writing of all subsequent documents.
- Using a dedicated Medical KPO team to write not only the major regulatory papers but also supporting regulatory documents (e.g., subject narratives, Informed Consent Forms, Risk Management Plans, Periodic Safety Update Reports) and materials based on information coming from regulatory documents (e.g., manuscripts, posters) guarantees uniformity and continuity, making the whole writing process more efficient.
- All papers profit from the work of a skilled writer.
Product Information (PI)
- PI is an essential component of a new medication or medicine’s application for marketing authorization. It contains the Summary of Product Characteristics (SmPC) and the Package Leaflet (PL) in the European Union; it identifies the authorization holder and specifies the terms of the authorization. The United States Prescribing Information is the counterpart of the SmPC in the United States (USPI).
- Medical KPO knows the objective and goals of the PI and can assist your teams in creating a paper that is a consistent depiction of the facts available from your clinical programs and submissions dossier.
New Drug Application (NDA)
- An NDA is a request for marketing approval of a novel medicine in the United States (“a product intended for use in the diagnosis, cure, mitigation, treatment, or prevention of illness or designed to modify the structure or any function of man’s body”).
- An Abbreviated New Medicine Application (ANDA) is a request for marketing approval of a generic drug based on a previously approved reference drug.
- The application contains pertinent clinical trial findings, CTD documentation, and the Risk Evaluation and Mitigation Strategies (REMS) document.
- Medical KPO may assist you with your documentation requirements and has the scientific competence and industry experience to provide the complete spectrum of evidence needed for your submission.
Clinical Trial Application Dossier
- As required by EU Regulation 536/2014, a clinical trial application dossier is submitted to a Regulatory Agency within a Member State of the European Union as the foundation for clinical study authorization.
- A completed clinical trial application form is included in the dossier, as are the following supporting documents: the Investigational Medicinal Product Dossier (IMPD), the Summary of Product Characteristics (SmPC), the research protocol, and the Investigator’s Brochure (IB).
- Medical KPO can assist you with your documentation requirements and has the scientific competence and industry experience to provide the complete spectrum of documents needed for your trial application.
Summary of Product Characteristics (SmPC)
- An SmPC specifies the drug’s agreed-upon use. It is an integral aspect of the application for marketing authorization of a new medication or treatment inside the European Union, and it includes information on use for healthcare professionals. The SmPC is part of the larger Product Information (PI) that also contains the Packaging Leaflet (PL) and identifies the permit holder as well as the authorization criteria. The United States Prescribing Information is the counterpart of the SmPC in the United States (USPI).
- Medical KPO knows the SmPC and USPI’s objectives and demands and can assist your teams in producing a document that is a consistent depiction of the data available from your clinical programs and submission dossier.
- Subject narratives, which describe individual subject experiences that require a detailed description, are an essential aspect of accurately documenting what occurred during a study and must be included in the Clinical Study Report (CSR).
- For maximum reading, narratives must follow a consistent framework, clearly putting forth the experiences of the many subjects in a way that is readily comparative. It must, however, explain the account of each subject’s circumstance so that a reviewer may properly analyze how the medicine may have had a part in the events that occurred.
- Medical KPO has extensive experience producing hundreds of topic narratives and is aware of regulatory reporting requirements and the necessity for uniform presentation
- Medical KPO writers may collaborate with the clinical teams to create a framework and template for the tales that will guarantee vital information is conveyed in an easy-to-find way while properly describing the topic occurrences. Our authors have extensive expertise in handling the full narrative production process, from the first meeting with the sponsor through contact with the project team, assuring on-time delivery, quality, and efficiency.
Statistical Analysis Plan (SAP)
- SAPs define the specifics of the proposed statistical analysis, expanding on the key elements of the technical analysis stated in the protocols. They might be incorporated in the clinical trial protocol or presented as a separate, related document.
- SAPs describe trial goals, data sources, populations examined, study endpoints, statistical techniques, sensitivity analyses, and missing data management, as well as the justification for why they are acceptable.
- Medical KPO can assist you with your documentation requirements and has the scientific competence and industry experience to deliver the complete spectrum of paperwork needed for your clinical study.
In The Field Of Pharmacovigilance
Aside from writing and providing assistance in the form of reports, we also give leadership and content writing to both current and new customers. We are well-versed in all the criteria for various kinds of safety reports.
Pharmacovigilance (PV) & Product Safety
- The increased emphasis on pharmacovigilance (PV), general medication safety, and clear information for patients is being driven by changing regulations and more litigation.
- Long-standing safety paperwork is being updated to portray the benefit-risk balance of medications more clearly, and new pharmacovigilance criteria are emerging as regulators strive to keep patients better informed.
- A previous European ASR (Annual Safety Report) and the United States IND Annual Report have been superseded by PBRER (Periodic Benefit-Risk Evaluation Report) as well as the Development Safety Update Report (DSUR).
- Risk Management Plans (RMPs), which have been required for all European drug submissions since 2012, must also (more recently) include a Summary of the RMP (Part VI) — a summary of the medicine’s hazards in patient-friendly language.
- We can assist you in assessing the requirements and preparing the necessary documentation. Medical KPO has the necessary experience to handle rigorous pharmacovigilance reporting.
- Our skill in providing safety data and pharmacological advantages in simple, accessible, and patient-friendly language lets us relieve you of one additional load. We also collaborate with an impartial physician who may give you the evaluation guidance you need.
To discuss your project writing requirements in confidence, please do not hesitate to get in touch with us.
When It Comes To The Clinical Trial Phase:
- Annual Reports of the Industrial Development Corporation
- Narratives of clinical SAE
In Order To Get The Go-Ahead For Marketing The Product:
- Clinical Safety Report: An Overview (CTD Module 2.7.4)
- A comprehensive overview of safety
- Education resources for EU RMPs, US REMS, and the like
- Searches for/reviews of relevant literature
This Is What You'll Need For When You've Finished Marketing:
- The EU PSURs/PBRERs
- PADERS/PAERs of the United States
- Safety Reports over the last 120 days
- Addendum to the Clinical Summary (for type II variations; changes to EU SmPCs)
- Safety evaluations and summaries, as well as ad hoc reports, are included.
- Documents Providing Answers to Questions
- Recommendation-Risk Reports
- Reports on the Evaluation of Signals of Potential Danger
- Education resources for EU RMPs, US REMS, and the like
- Searches for/reviews of relevant literature
Medical Writing For Pharmacovigilance: What Is It?
At every level of the drug development process, pharmacovigilance medical writing is critical.
Pharmacovigilance medical writing is needed at every step of the process, from BioPharma current studies to the submission of reports required for marketing authorization. In order to successfully navigate the many sets of technical requirements, a team of specialized writers is needed.
Annual DSURs in the EU and IND Annual Reports or DSURs in the US are used to report on the safety of participants in clinical trials during the clinical development phase of any medicine.
Submissions for marketing authorization often include BioPharma current studies analyzing safety data as a key element of the paperwork.
PSURs, PBRERs, RMPs, and ad hoc safety evaluations need to be written by pharmacovigilance medical writing professionals once marketing authorization has been obtained.
The demand for pharmacovigilance medical writing knowledge stays continuous since RMPs and Benefit-Risk Evaluation Reports are updated during the length of a product’s life cycle.
Documentation Pertaining To Compliance With Laws And Regulations
The success of every drug development program hinges on the quality and conciseness of the regulatory paperwork.
Our extensive expertise in this field as a writing service with an established track record of accomplishment assures a seamless transition from submission to approval.
- The Standard Technical Document (CTD)
- Clinician’s reports
- Clinical summary
- Summaries of non-clinical data
- A non-clinical perspective
- Applications for New Drugs (NDAs)
- Approval Requests for Marketing (MAAs)
- Additional NDAs and MAA iterations
- Preparation of the main document
- Responses from the regulatory authorities
- Summary (ISS/ISE) includes both safety and effectiveness information.
- Clinical research reports (Phase I – IV)
- Serious adverse events (SAEs)
- Reports of Clinical Evaluation (CERs)
- Reports that are not clinical in nature.
- Briefing papers are a kind of document
Your Need Multiple Clinical Documents
Medical KPO can handle all of your clinical paperwork for you. We have vast expertise in generating clinical documentation and CTD submissions of various varieties. We have written hundreds of CSRs for all stages of clinical development and for the vast majority of indications. We’ve also designed and executed hundreds of CTDs, ranging from simple local modifications to extensive worldwide submittal dossiers. In a nutshell, we have the ability and expertise to satisfy the demands of any development program, no matter how complicated it is. We attempt to anticipate your documentation requirements and to provide the greatest possible relationship between the many papers generated at various phases of the development cycle, guaranteeing effective and timely preparation.
Medical KPO may handle your whole documentation requirements as part of a “functional outsourcing” clinical development team, depending on your yearly program of work – functioning as an indispensable “glue” to link disparate organizations and places together through documentation. As a “catalyst,” we actively push the clinical team throughout the development and documentation phase – to keep communications clear – while project managing – to maintain papers on time.
- Postmarketing research has become more crucial to preserve medication approval, get adequate reimbursement, and enhance clinical access.
- Medical KPO can offer customized advising and high-quality documentation writing for your whole postmarketing program, including post-approval safety studies (PASS) and accompanying submission dossiers.
- Users can assess and advise you on the types of studies that may generate the documents required to meet the postmarketing objectives, and we can provide you with all the documents required from program inception to submission to reimbursement bodies such as NICE or IQWIG, as well as conferences and journals.
- We know how to properly explain novel research designs, complex statistics, and postmarketing clinical data reporting, giving you the highest chance of success for your program.
Among our qualifications are:
- Documents from a phase 4 (late phase) clinical study
- Documents from an observational study
- Reports on Health Technology Assessment (HTA)
- Documents on health economics
- Documents pertaining to the patient registry
Various Products And Services
In addition, we provide the following clinical data science services:
- PSURs, DSURs, RMPs, and safety narratives
- Product-specific answer papers in the fields of neurology, cancer, endocrinology, and reproductive therapy in response to medical information requests
- Novel foods, food supplements, and health claims
- Non-clinical In-licensing and out-licenses:
- Reports on chemical industrial toxicology: SDS, REACH reports, and other such documents
- The process of tracking down and corresponding with academics and other influential figures
- Translations of medical and scientific texts
- Consultation and training
- Website content for medical and scientific fields
- Research in books and databases
- Conceptual input, quality control, and quality assurance of texts, tables, and images are all part of editing and proofreading.
- Brochures containing scientific information
- Operational practices (SOPs)
Interested parties may contact Medical KPO for further information on this.