Question 1

REGULATORY DOCUMENTATION

Accepted Answer

We can prepare or provide guidance on a wide range of regulatory documentation involved in the drug regulatory process, which includes:
• Module 2 and Module 5 documents
• MAAs, INDs, NDAs, BLAs
• 90 and 120 day updates
• Nonclinical Study Reports and Overviews
• Response to regulatory queries
• Briefing Documents and Meeting Requests
 
All regulatory documentation will be written in accordance with ICH-GCP compliant standards, and as per client specifications. Each document will be written to the highest standard in an accurate and concise manner with the aim to preventing ambiguity and smooth submission.

Question 2

CLINICAL STUDY DOCUMENTION

Accepted Answer

We can also prepare or provide guidance on clinical trial documentation, namely the following:
• Clinical Study Reports (Phase I to IV)
• Clinical Study Protocols and Amendments
• Investigator Brochures (IB) and IB updates
• Patient Information Leaflets
• Informed Consent Forms
• Literature Searches
• Reclassification Overviews
 
We will aim to ensure that all clinical documentation is prepared free of ambiguities or any other issues which could prevent the smooth conduct of a clinical study or management of a study by an Investigator. In the case of Study Protocols, we will endeavour to produce a protocol that has the greatest chance of obtaining approval from the appropriate International Regulatory Board or International Ethics Committee it is submitted to.

Question 3

PHARMACOVIGILANCE AND SAFETY REPORTING

Accepted Answer

Our team of writers have experience in pharmacovigilance and safety reporting and having the following experience within this field:
• Evaluation of aggregate safety data
• Authoring of PV reports, PSURs/DSURs, PBRERs, ACO, RMPs and safety narratives
• Signal detection, evaluation and reporting
• Experience using ARGUS safety database
• Involved in process of Signal detections, evaluation and reporting

Question 4

CLINICAL TRIAL DISCLOSURE AND DATA TRANSPARENCY

Accepted Answer

• Delivery of practical support to clients to ensure compliance with applicable global and regional registries' regulations/guidelines
• Protocols registration and results summary preparation/posting on Clinical Trial Registries including ClinicalTrials.gov, EudraCT and national registries
• Study results preparation and posting for EudraCT
• Lay summary preparation
• Preparation of redacted/anonymised documents
• Active interaction within cross-industry Clinical Trial Transparency Working Groups and initiatives
• Plain Language Summaries

Question 5

MARKET ACCESS

Accepted Answer

• Abstracts and Posters for International HEOR Conferences
• HEOR Manuscripts and supporting Global Value Dossiers
• Input in terms of clinical data, cost and resource use, and epidemiology related data

Question 6

SCIENTIFIC DOCUMENTATION

Accepted Answer

Our team of writers can also prepare or provide guidance on any type of scientific documentation. We offer a wide range of services under this category:
• Dissertation, essay and assignment proof-reading (blogs, articles, website content, slide share, study materials, teaching manuals, book chapters, research articles, and SEO-oriented articles)
• Scientific component authoring
• Monographs, newsletters
• Publication Planning
• Publications for scientific journals
• KOL Mapping
• Storyboarding e-learning modules
• Slide decks and Posters for scientific conferences and corporate presentations
• Manuscripts
• Literature Searches and literature evaluation and preparation of systematic reviews
• Abstract
 
Well-versed in the field of academia and medical communications, our team of medical writers can provide you the document you need for whatever audience. We also provide a professional “proof-reading” service available to anyone from students to companies to agencies or novelists. If spelling or grammar is not your strong points, lean on our expertise.

Question 7

REGULATORY PUBLISHING AND DOCUMENT TRANSFORMATION

Accepted Answer

Electronic and Paper publishing
Compilation and creation of an eCTD compliant submission
Adjusting document granularity to work with eCTD and CTD, and to ICH GCP E3 section  
Publishing CTD from eCTD
Addition of Tabs, Slip Sheets and bookmark and hyperlinks to PDF
Compilation, creation and validation of NeEs and eCTD submissions.
Creation and validation of document templates
Addition of company headers and footer information
Redacting and cleaning documents of black shadows
Scaling pages to within company defined margins
Addition of document-level, volume-level or CSR level pagination
Implementation of additional eNavigation to aid review
CRF PDF processing, hyperlinking, and bookmarking
Word to PDF troubleshooting and remediation
Technical checking of WORD document for compliance issues

Question 8

MEDICAL COMMUNICATIONS

Accepted Answer

Medical communications
Our medical communications team is equipped to develop high quality, credible, expert medical and scientific promotional and non-promotional communications across a variety of channels. From conception to execution, our medical copywriters will provide strategic council and dedicated support throughout the creation process to develop a compelling advertising campaign and ensure that your brand is represented to a high standard.
Medical copywriting
Print, digital, web and online including SEO
Videos, interactive learning tools

Question 9

MEDICAL DEVICES

Accepted Answer

Clinical Evaluation Reports (CERs):

Our team of experts excel in developing detailed Clinical Evaluation Plan (CEPs) and Reports (CERs) that showcase the State-of-the-Art (SOTA) establishment and demonstrate the benefit risk ratio of devices under evaluation. Through systematic literature searches, we will meticulously gather and analyse relevant data, incorporating the latest findings into your reports. We ensure seamless integration of regulatory standards, including MEDDEV, MDR, MDCG guidelines, and IMDRF guidelines, ensuring your products are in complete compliance.

Risk Management Files:

Mitigating risks is essential in the medical device industry. Our team of experts are skilled in developing Risk Management Files in collaboration with product owners to meticulously identify, assess, and control risks associated with your product. We ensure your Risk Management Files meet the highest regulatory standards, including ISO 14971, safeguarding your products and your customers.

Biological Evaluation:

Understanding the biological safety of medical devices is paramount. Our experts conduct thorough biological evaluations, employing the latest scientific methodologies to assess the biocompatibility of your products. We provide comprehensive documentation, demonstrating compliance with regulatory requirements such as ISO 10993, ensuring the safety of your products.

Post-Market Clinical Follow-up (PMCF) Studies:

Continuous monitoring through PMCF studies is indispensable. Our dedicated team assists you in designing and conducting PMCF studies. These studies will enable you to gather real-world data, assess long-term performance, and address potential issues. By conducting PMCF studies, we ensure your products consistently comply with regulatory authorities, including MDR Article 83, MDCG guidelines, and IMDRF guidelines.

Periodic Safety Update Reports (PSUR):

PSURs are vital components of post-market surveillance. Our experts compile detailed PSURs, summarising the safety and performance of your medical devices over time. By integrating PMCF data, adverse event reports, and other relevant information, we create PSURs that comply with regulatory standards. These reports facilitate ongoing compliance with MDR requirements, ensuring your products are continuously safe and effective.

Question 10

BIOSTATISTICS

Accepted Answer

Biostats and Medical Writing go hand in hand, and as such, Armah Consultants works closely with a crop of talented Biostatisticians, who have the expertise to lead discussions in the development of clinical protocols (including but not limited to discussions on endpoint selection, sample size, methodology, analysis, and study design development) and propose analytical strategies.
Our Biostatisticians have experience managing all statistical aspects of clinical studies using SAS and R Programming, CDISC, and numerous other statistical computation programs. 
Our focus is on delivering quality results to our client’s and ensuring all work is completed within budget, to the highest standard and in a timely manner. Equipped with a statistical "know how" our Biostatisticians can provide input and author/co-author, develop, and review statistical analysis plans, CSRs, abstracts, and manuscripts, using their knowledge to advise, provide guidance and to oversee the quality control of statistical deliverables, across all phases of clinical development, as well as HEOR, RWE and PMOS.

Question 11

QUALITY CONTROL

Accepted Answer

Quality Control (QC) is an essential part of all authoring, particularly within the drug development industry. Whether we are required to perform QC as a standalone project, or as part of a project, all our writers have a meticulous attention to detail and take pleasure in performing these checks.
Prior to completion, all documentation undergo a thorough proof-reading and QC validation process.  During which, we will ensure the content, format and style of all documents are of the highest quality.

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