on point medical writing capabilities

OnPoint Consulting provides niche services to the Biopharmaceutical, CRO and Medical Device industries.

Our diverse team of highly experienced professionals deliver the competitive edge necessary in today’s market.

Our Services

• Medical Writing Services• Clinical Monitoring Services• Pharmaceutical Research Staffing Services

Medical Writing Services

•Subject-matter expertise to support project implementation and completion•Interfacing, collaborating and delivering within diverse team environments•Ability to meet the demands in fast-paced environments with changing priorities•Effective project management with the ability to handle multiple projects simultaneously

Document Experience

• Protocols and amendments

• Investigator brochure• Informed

consent/assent• Clinical study report• Benefit-Risk portfolios• Safety narratives• Briefing documents

• CTD/IND/NDA compilations• Integrated summaries of

safety/efficacy• Literature summaries• Editorial/Quality Control

review• Annual reports• Template preparation/editing

•Regulatory Focused Expertise•Flexibility•Experienced Project Management•Pricing

Benefits Utilizing OnPoint

NUMBER OF REGULATORY DOCUMENT DELIVERABLES*

OnPoint Deliverables

* Protocols and study reports cover Phases 1 through 4, inclusive

• Analgesia• Cardiology• Neurology• Dermatology• Gastroenterology• Endocrinology• General Medicine• Immunology

• Neurology• Oncology• Pediatrics• Psychiatry• Ophthalmology• Rheumatology• Women’s Health• Medical Devices

Therapeutic Experience

High Quality Deliverables

Our Medical Writing group is comprised of highly experienced quality control review and document specialists. The writing team is in turn supported by subject matter experts (medical, regulatory or scientific), graphic designers, document processors, biostatisticians and language experts.

Committed to maintain high standards of excellence by ensuring customers’ideas are clearly communicated to their specified target audience. This is achieved through extensive research, writing of well-structured documents and consistent editing.

Deliverable

MEDICAL WRITER

Cross Functional Approach

Added Value• Process design is tailored to client needs, ensuring high

quality from inception to completion.• Highly experienced medical writing staff with post-graduate

degrees in pharmacy, medicine and other life science subjects.

• Expertise in preparing and writing of documents across a wide range of therapeutic areas.

• Completion of writing projects within given deadlines.• Preparation of regulatory and clinical documents according to

relevant guidelines.• Convenient, flexible and cost-effective pricing structure.

For further information or follow up, please contact:

Tricia Foster | Account Managertricia@opsvs.com | www.opsvs.com | 856-693-2500

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