Preclinical and Clinical Development Services

A successful clinical program is part of an integrated, stepwise process that begins with the design of an overall development and approval strategy and proceeds through

• design and execution of appropriate preclinical investigations,

• refinement of the clinical program based on the outcome of the preclinical work, and

• design and execution of a clinical program optimized for the widest indication and largest target population, for the lowest cost and shortest time to market.

These objectives are best achieved by frequent consultation with FDA and foreign regulatory agencies as appropriate.

With over two decades of experience directing clinical development programs leading to more than 20 US FDA product approvals, LSP is uniquely positioned to provide the highest quality clinical services in the areas outlined below, to help you pave a successful path to approval for your product.

Prepare clinical development strategy and assess regulatory requirements for approval

• Design clinical trials

• Identify appropriate and achievable end points

• Determine required preclinical investigations

• Design, supervise and manage preclinical studies

• Qualify and select contract laboratories

• Assist with planning and execution of pre-IND meetings with FDA

Perform clinical trial preparation

LSP has broad experience in designing and initiating clinical trials, from Phase I through Phase IV.

©2000, Photos To Go

• Refine clinical trial design; determine appropriate subject demographics and subject population size

• Harmonize clinical development plans for regulatory approvability in several countries

• Prepare clinical protocols, case report forms, patient diaries, and investigator’s brochures

• Prepare informed consent and HIPAA authorization documents

• Draft, negotiate and conclude investigator’s and institutional budgets and research agreements

Identify and recruit clinical investigators

Benefit from LSP's extensive international network of collaborators, colleagues and thought leaders in several therapeutic areas.

Manage the clinical program

LSP has directed clinical programs leading to more than 20 FDA approvals.

• Select and qualify contract research organizations (CRO)

• Manage Institutional Review Board/Ethics Committee submissions

• Supervise and manage CRO performance

• Perform as liaison with investigators and clinical sites

• Plan and manage investigator meetings and symposia

• Initiate clinical sites

• Implement strategies for optimal subject recruitment

• Perform Good Clinical Practice (GCP) compliance audits

Help with planning and execution of FDA meetings and teleconferences