Services

Offering simple solutions in a complex industry

Medical Writing 

We specialize in crafting comprehensive, compliant, and meticulously researched written documents to support every stage of your clinical development. From pre-IND briefing documents, protocols and investigator brochures, regulatory submissions and patient consent forms, all the way to CSR and manuscript writing, we provide a comprehensive suite of services to ensure your trial progresses smoothly and efficiently. With a keen understanding of regulatory requirements and industry standards, we deliver high-quality, precise, and timely documentation, empowering you to navigate the complexities of clinical research with confidence and clarity.

Pre-IND Briefing Documents

Protocol

Investigators Brochure

Informed Consent Form

Patient-Facing Documents

Study Plans and Manuals

eCRF Design

Annual Reports

Clinical Study Report

NDA Information Requests

Manuscripts

Operational Oversight

We offer operational oversight to ensure the success of your clinical trials that eliminate the need for costly large-scale solutions, or if large scale solutions are needed, we are able to bridge the gap and provide oversight on your behalf. Our expert services cover every phase of your study start-up, including complete vendor selection, strategic study design, feasibility assessments, and targeted site identification. We prioritize building strong site relationships and offer thorough team and investigator training to guarantee a smooth initiation process. Our project management services are designed to keep your trials on track, with dedicated functional team oversight and rigorous quality management to ensure the highest standards of compliance and performance, resulting in high quality data. 

Study Start-up:

Project Management

Functional Team Oversight

Quality Management

General Scientific Consulting

We provide extensive general scientific consulting tailored to meet your specific needs. Our expertise encompasses strategic protocol design, ensuring that your clinical studies are both scientifically robust and regulatory compliant. We offer comprehensive clinical development planning to guide your projects from concept through completion, along with dedicated clinical scientist support to enhance the scientific integrity of your trials. Our range of essential services is designed to empower your team with the knowledge and resources needed to achieve clinical excellence. Partner with us to advance your research with precision and strategic insight. 

Strategic Protocol Design

Clinical Development Planning

Clinical Scientist Support

Outsourcing Management

Let us handle the partners it takes to get across the finish line. We specialize in outsourcing management, providing a seamless integration of external resources to support your clinical research needs. Our services include meticulous vendor selection, encompassing CROs, laboratories, IP distribution and management, imaging, and other specialty vendors. We develop comprehensive RFPs, conduct thorough budget and specification analyses, and manage relationships to ensure optimal collaboration and efficiency. Additionally, we cultivate strong partnerships with Investigators and sites to foster a cooperative and productive research environment. Rely on our expertise to streamline your outsourcing processes and enhance the success of your clinical trials. 

Vendor Selection

RFP Development

Budget Analysis

Specifications Analysis

Vendor Oversight

Investigator/KOL Partnerships

Site Network Partnerships