OUR BUSINESS
Pearl Productions Ltd. is an independent consulting company that specialises in freelance regulatory medical writing. We are based in Vancouver, Canada but our clients come from all over the world.Pharmaceutical companies have a substantial investment in their data. Years of effort covering different eras in a drug's developmental history and volumes of background research must be summarised quickly and meet the expectations of regulatory agencies. This places a demand on companies for unequivocal writing and an accurate and clear description of the results.
Contracting writing projects to an experienced writer can help you meet this challenge. This gives you the flexibility to add medical writing capability to your project team as the need arises. Depending upon availability, you can add as much or as little writing capability as your project requires. Whether it's a protocol, a study report, or an actual phase-3 submission, Pearl Productions can help you meet your goals. We will work with your in-house team to ensure that your documents meet high standards, follow relevant guidelines, and comply with agency regulations and expectations. The documents that we produce comply with ICH and GCP guidelines as well as client-specific templates.
OUR EXPERIENCE
Our medical writer, Michael Weaver, PhD, has a PhD degree in Microbiology and Immunology. He supplemented this degree with a fellowship in Clinical Immunology at the UCLA Medical Center. Following this he worked for 10 years managing hospital laboratories covering the specialities of hematopathology, immunology, and transplantation. Through his research training and work experience, he is especially familiar with HIV therapy and bone marrow transplantation. His medical writing experience during this time included patient reports, research manuscripts, review articles, and grant proposals. Since 1996, he has worked exclusively as a pharmaceutical medical writer producing clinical and regulatory documents for pharmaceutical clients. Because of his clinical background, he specialises in reviewing safety data. He has worked for pharmaceutical companies and contract research organisations based in Europe, Canada, and the United States. He is familiar with Microsoft Word and Excel as well as common charting and statistical programs. He is a current member of the American Medical Writers Association and keeps in step with evolving changes in regulatory requirements by participating in regular professional education workshops and symposia.
MEDICAL WRITING SERVICES:
| Regulatory documents including clinical study reports; consent forms; investigator brochures; investigational new drug applications (INDs); manuscripts; patient narratives; protocols; statistical plans; and summaries of efficacy, safety, pharmacokinetics, and toxicology | |
| Manuscripts | |
| Quality review of source documents, case report form tabulations, and statistical summary tables |
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| Safety data review, reconciliation of data base output against source documents |
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| Editing and formatting of text for scientific/ medical articles and web sites |
CLIENT PROJECTS HAVE INCLUDED THE FOLLOWING THERAPEUTIC INDICATIONS:
| Alzheimer's disease |
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| Anaemia |
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| Bone marrow and hematopoietic stem cell transplantation |
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| Diabetes |
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| HIV disease, therapeutics, and vaccines |
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| Infectious disease and anti-infectives |
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| Oncology (esophageal carcinoma, glioblastoma multiforme, melanoma, prostate cancer, skin cancer) |
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| Obesity |
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| Ophthalmology |
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| Psoriasis |
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| Solid organ transplant |
OUR CLIENTS INCLUDE:
| Pharmaceutical companies |
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| Contract Research Organisations |
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| Academic clients |
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| Publishers |
CONTACT INFORMATION:
For more information please contact:Michael Weaver, PhD
Pearl Productions Ltd.,
6631 Steveston Highway,
Richmond, BC, Canada
V7E 2L2
Tel. (604) 841-6756 [PST (GMT-9h)]
All rights reserved © Pearl Productions Ltd. 2007
Revised October 18, 2007
