Medical Writing Services

Ensure you meet regulatory requirements through precise clinical trial documentation.

Precise and thorough medical writing during the clinical research process is vital to any clinical trial.

Our expert team produces high-quality documentation that meet regulatory requirements and support your clinical development programs.

Engage

Our medical writers bring both regulatory and technical expertise to deliver comprehensive writing services tailored to your needs.

We work as an integrated extension of your team, with the same project managers throughout your program, ensuring seamless continuity, transparency, and strategic alignment while delivering clarity and accuracy at every stage.

Our Approach Medical Writing Services Before you start

Professional clinical trial documentation

Our medical writers have experience across therapeutic areas from early phase to post-approval.

Support your clinical trial documentation with accurate protocols, amendments, and clinical study reports that adhere to regulatory compliance.

Expertise and Precision

Our team comprises experienced medical writers with deep knowledge of regulatory requirements and clinical research.

Tailored Solutions

We customize our writing services to fit your unique project needs, timelines, and regulatory expectations.

Quality Assurance

Each document undergoes a rigorous, cross-functional review process to ensure accuracy, consistency, and completeness.

End-to-End Support

From initial protocol development to final study reports, we provide comprehensive support throughout your clinical research journey.

Regulatory Services

Our Medical Writing Services

Clinical Protocol Development

Comprehensive Protocols:
We develop detailed clinical protocols that outline the objectives, design, methodology, statistical considerations, and operational aspects of your clinical trial, incorporating information from past precedent and similar products.

Regulatory Compliance:
Our protocols are crafted to meet the stringent requirements and prior correspondence from regulatory authorities, ensuring a smooth approval process from pre to post-market.

Collaborative Approach:
We work closely with your team to incorporate specific project needs and scientific rationale into the protocol. Our clinical and regulatory teams work together to ensure both operational and regulatory needs are met.

Clinical Protocol Review

Expert Review:
Our team provides comprehensive reviews of clinical protocols, evaluating medical feasibility, execution viability, and alignment with standard of care. We ensure protocols are scientifically sound, clearly written, and practically executable to support your specific device or drug objectives

Feedback and Revisions:
We provide comprehensive feedback and work closely with your team to implement revisions that strengthen protocol quality and scientific rigor.

Clinical Study Reports (CSRs) / Clinical Investigation Report (CIRs)

Comprehensive Reporting:
We prepare detailed final study reports that summarize the methodology, results, and conclusions of your clinical trials.

Regulatory Submission:
Our reports are formatted to meet the requirements of regulatory agencies, facilitating the submission and review process.

Data Integration:
We ensure seamless integration of data from various sources, presenting a clear narrative of your study findings.

Other Medical Writing Services

Investigator Brochures:
Creation of comprehensive brochures that provide investigators with essential information about the investigational product.

Informed Consent Forms:
Development of clear and understandable consent forms that comply with ethical and regulatory standards.

Regulatory Documents:
Preparation of various regulatory documents including IDEs, INDs, NDAs, and annual reports for your drugs, device, and biologics.

A Good Place to Start

To begin with our Medical Writing services, we recommend having as much of the following information ready, as possible:

Study Objectives and Design

Clear goals and a well-defined study design.

Regulatory Requirements

Specific regulatory guidelines, requirements, or prior communication with regulatory agencies that are pertinent to your project.

Background Information

Comprehensive details about the investigational product, including any available preclinical and clinical data.

Timeline and Milestones

Key project timelines and milestones to ensure timely delivery of documents and alignment on expectations.

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

Proxima has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.

CSO

Mark Cantwell

Proxima was instrumental to our success in getting breakthrough device designation for our product! The team was very knowledgeable and responsive and set us up for success. They made the FDA process easy to go through and prepared us for future interactions with FDA.

Co-Founder

Jade Doucet-Martineau

Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey.

Physician

Chester J. Koh, MD

We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!

Regulatory & QA Manager

Michael Selva

“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”

Founder

Marc Bessler, M.D.

"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."

COO & Co-Founder

Geoffrey Lucks

"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."

Founder & CEO

Robert Whitehead

We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.