FIM Packages

Two Step FIM Package
A two step approach to FIM package completion is tailored to the specific needs and properties of your development program. The first step includes analytical and bioanalytical  method development, tox species selection and preliminary pharmacokinetic and safety assessment (MTD, dose range finding) services. The second step includes method validations and GLP pivotal toxicology, safety pharmacology  and gene toxicology services.

As Accelera is able to perform the entire package of studies on-site, enhanced efficiency and scientific integration are assured.

Accelera's Programme Leader
Due to our unique history as part of an international pharmaceutical company, Accelera is able to offer a key service assigning a senior scientific leader to act as a single point of contact for all study related communications, ensure regular updates and consistency of reporting across all activities.

Optimised Cycle Times
Accelera's commitment to optimized cycle-times (e.g.: 6 months avg. from 1st GLP study to draft IND/IMPD documents) has been attained in a number of collaborations to drug development programs, including novel anticancer agents with Biotech and Pharma sponsors, anti-infective agents by US Biotech and EU Pharma companies, CNS programs with Italian Biotech and Pharma sponsors, neglected disease projects for non-profit organizations.