- International Service
Clinical Trials
Precision, Compliance, and Clarity in Clinical Trial Documentation
Clinical trials are the backbone of medical advancements, requiring meticulously documented research to ensure regulatory compliance, scientific accuracy, and publication success. At ScienceBy, we specialize in crafting clear, precise, and regulatory-compliant documents to support researchers, pharmaceutical companies, and healthcare organizations in every phase of their clinical trials.
Our Services
Site Setup & Operational Documents
Before initiating a clinical trial, essential documents must be prepared to ensure regulatory approval, site readiness, and compliance with Good Clinical Practice (GCP) guidelines.
- Site Standard Operating Procedures (SOPs)
- Investigator Site Files (ISF) Documentation
- Essential Regulatory Documents Binder
- Essential Regulatory Documents Binder
- Clinical Trial Agreements (CTAs) & Contracts
Clinical Trial Protocol Development
A well-structured clinical trial protocol is critical for regulatory approvals and successful trial execution. Our experts develop clear, compliant, and scientifically robust protocols that align with international standards such as ICH-GCP and regulatory agency guidelines.
- Clinical Study Protocols (CSPs)
- Protocol Amendments
- Investigator’s Brochures (IB)
- Synopsis & Protocol Summaries
Regulatory Submission Documents & Dossiers
Regulatory submissions are complex and require precise documentation to ensure approval from agencies like the FDA, EMA, MHRA, Health Canada, and PMDA. Our team ensures that all submissions are scientifically accurate, regulatory-compliant, and strategically structured.
- Common Technical Document (CTD) Modules
- Investigational New Drug & New Drug Applications
- Clinical Trial Applications (CTA)
- Risk Management Plans (RMPs)
- Periodic Safety Update Reports (PSURs) & Development Safety Update Reports (DSURs)
Clinical Study Reports (CSRs) & Safety Narratives
Once a clinical trial concludes, detailed study reports are required for regulatory submission and scientific communication.
- Clinical Study Reports (CSRs)
- Clinical Study Reports (CSRs)
- Clinical Study Reports (CSRs)
- Pharmacovigilance & Risk-Benefit Analysis Reports
Patient & Investigator-Focused Documents
We ensure that all stakeholders-patients, investigators, and ethics committees have access to clear and compliant information.
- Informed Consent Forms (ICF)
- Lay Summaries of Clinical Trial Results
- Lay Summaries of Clinical Trial Results
- Patient Diaries & Questionnaires
Scientific Publications & Medical Writing
Transforming clinical trial data into impactful scientific publications is crucial for knowledge dissemination and regulatory success. We provide:
- Clinical Trial Manuscripts
- Systematic Reviews & Meta-Analyses
- Abstracts & Conference Posters
- White Papers & Medical Communications
Post-Trial & Real-World Evidence (RWE) Writing
After a drug or device enters the market, real-world evidence (RWE) and post-market surveillance become essential for regulatory agencies, healthcare providers, and policymakers.
- Post-Marketing Surveillance Reports
- Health Technology Assessment (HTA) Dossiers
- Real-World Evidence (RWE) Reports
- Pharmacovigilance & Drug Safety Reports
Custom Clinical Writing Solutions
If your project requires specialized scientific writing beyond the listed services, we offer tailored solutions, including:
- Regulatory responses to agencies like the FDA & EMA.
- Regulatory responses to agencies like the FDA & EMA.
- Regulatory responses to agencies like the FDA & EMA.
- Grant proposals and research funding applications.
Why ScienceBy?
Expert Medical Writers
Our team consists of experienced professionals with expertise in regulatory writing, medical writing, and clinical research.
Regulatory Compliance
We adhere to international guidelines such as ICH-GCP, FDA, EMA, and CONSORT.
Scientific Accuracy
Every document is thoroughly researched, fact-checked, and aligned with the latest industry standards.
Clear & Concise Writing
We simplify complex clinical data into precise, reader-friendly content for various stakeholders.
Confidentiality & Ethics
We prioritize data security and ethical considerations in all our writing services.
Resources
Explore our resources to enhance your writing skills and navigate the publication process with confidence.
General FAQs
What types of clinical trial documents do you provide?
We offer a full range of clinical trial documents, including protocols, investigator’s brochures, clinical study reports (CSR), case report forms (CRF), regulatory dossiers (NDA, IND, BLA, CTD), site SOPs, informed consent forms (ICF), and pharmacovigilance reports.
Do you follow global regulatory guidelines (FDA, EMA, ICH-GCP, etc.)?
Yes, all our documents adhere to international regulatory standards, including FDA, EMA, ICH-GCP, CONSORT, ISO (for medical devices), and local regulatory requirements.
Can you help with regulatory submissions and dossier preparation?
Absolutely! We prepare submission-ready Common Technical Document (CTD) modules, IND/NDA/BLA applications, clinical evaluation reports (CER) for medical devices, and ethics committee (IRB/EC) submissions.
Do you offer writing services for early-phase and late-phase clinical trials?
Yes, we support Phase I to Phase IV clinical trials, including first-in-human (FIH) studies, dose-escalation trials, pivotal studies, and post-marketing surveillance (PMS).
How do you ensure data confidentiality and security?
We comply with strict confidentiality agreements (NDAs) and follow GDPR and HIPAA guidelines for data security. All documents are handled securely, and access is restricted to authorized team members only.
Can you assist with journal publications and conference abstracts?
Yes, we provide end-to-end support for manuscript writing, journal selection, formatting, submission, and peer-review responses. We also create abstracts, conference posters, and white papers to showcase clinical trial results.
Do you offer patient-centered documents, such as lay summaries and informed consent forms?
Yes, we specialize in patient-friendly materials, including lay summaries of clinical trial results, patient education brochures, and simplified informed consent forms that meet regulatory requirements.
How do you ensure accuracy and quality in clinical trial writing?
All documents undergo a multi-step quality control (QC) process, including scientific fact-checking, regulatory compliance checks, and medical editing. We also provide internal and external peer reviews to enhance accuracy.
What is your typical turnaround time for document preparation?
Timelines vary based on the document type and complexity, but we offer flexible turnaround times ranging from 5-15 business days for most documents. Expedited services are available for urgent projects.
How can we get started with your clinical writing services?
Simply contact us via email or phone for a free consultation. We will discuss your needs, propose a timeline, and assign the right experts to your project.