Clinical Services & Medical Writing

Optimized, proactive processes identify the best-performing sites and yield the target number of qualified patients in the shortest possible time.

We are committed to recruiting in the shortest possible time the target number of patients who meet inclusion/exclusion criteria, and to maintaining investigational site performance, motivation and quality throughout the recruitment period. Our electronic tools and management structure has allowed us to establish numerous industry benchmarks, including enrollment records in four therapeutic areas. Many projects, including first in an area, have produced industry records.

We maintain an extensive database of sites and rank each we have worked with. We do not restrict site selection to a list of 'preferred sites'; rather, we select sites based upon their therapeutic expertise, ability to interact with electronic systems, their commitment to timeliness and quality, and a realistic prediction of recruitment.

Meeting Recruitment Goals

We emphasize the following strategies:

• Excellent site relationships so that our studies receive priority when appropriate patients are identified. We sustain site relationships in many ways, most importantly through listening to site issues and responding quickly.
• Where appropriate, we use patient advertising to attract patients to studies. We have successfully used a variety of media, including GP surgery posters, radio advertising, newspapers, and the internet. Prospective participants, who respond to an advertisement, undergo telephone screening comparing their eligibility against a study-specific script. This approach eliminates extraneous formal screening visits for clearly ineligible patients and avoids wasting the investigator's valuable time.
• Identify sites that are recruiting poorly and respond appropriately. We ensure that all sites are aware of enrollment rates at their own site and the other sites via the internet using competitive enrollment tactics. If remedial efforts fail to show quick results, we cut poor performers.
• We may set up reserve sites which can be brought in at short notice should the need arise.
• While recruitment is ongoing, we vigilantly monitor external factors potentially affecting recruitment rates, such as negative media coverage about the drug class, holiday seasons, etc.
• Our electronic systems allow us to track performance with great sensitivity in this critical early phase of a clinical trial, and our Smart Monitor™ program enables us to identify any specific inclusion or exclusion criterion that may be inhibiting recruitment. We will work with our clients to see whether a protocol amendment may be viable.

Writing focuses on clarity and brevity. ICH guidelines provide the structure for a CSR, but elegance is reflected by concise, focused descriptions of the data and the means by which they were collected, including qualifications. Our writing is performed primarily by personnel involved with the study, working closely with senior staff who have extensive experience in working with the FDA, EMEA, and other regulatory agencies. Advance planning and preparation of tables shells, analysis programs, and background components enables us to prepare draft CSRs within weeks of database lock.

Our senior staff is also experienced at writing materials for scientific presentation, including seminars, meetings, and manuscripts. This is a different type of writing, intended for a scientific audience and demands an even greater degree of precision. Our senior writers have published more than 200 articles, including in leading peer-reviewed journals. Our staff also serves as referees and on editorial boards.