Providing Manpower to Speed up Phase 2 of Clinical Trial



About the Client

The end customer is a multi-billion dollar Pharmaceutical company with 6,000+ employees

Business need

The customer wanted to speed up the analysis process during the Phase 2 of the Clinical Trial phase for a cancer medicine.With 180+ participants,the trial is expected to run across the US region. It involves collection of data from
participants to assess dosing and efficacy of the new intervention. The challenges in this process include:

  • To identify and engage experienced resources who can analyze and generate clinical reports for FDA submissions
  • To generate reports to obtain additional safety data to obtain FDA and EMA approval

Solution delivered

ALTEN Calsoft Labs with experience in identifying consultants for a specific study helped in identifying the suitable candidates.We also engaged trained and internal pool resources within few days of signing the SOW.Key highlights
of this engagement includes:

  • Ramped up resources from 2 to 23 within 2 weeks
  • Conducted 125+ interviews within 2 weeks and on boarded 9 candidates in a short time
  • Trained consultants on CDISC standards to become aware and follow the trial process

Business benefits

  • Deliver better services by providing consultants on time
  • Lower cost yett skilled resources helped saving project cost
  • Improved joining rate and stable resources in the engagement

Technology stack

  • SAS Drug Development
  • FDA, CDISC, ADaM, 21 CFR Part 11

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