Clinical development services are often only partially outsourced. Some sponsors prefer to manage the trial themselves due to an affinity for the science involved or perception that the trial's complexity is better handled internally. For this reason, a flexible partner is ideal to ensure the sponsor's needs are being met efficiently and effectively.

1. Creating Actionable Solutions
Why Covance?
This sponsor was looking for a partner that could:
Non-recruiting sites represent a significant cost drain, both in terms of direct site startup costs, and ongoing site
management and monitoring costs. Covance sought to reduce the proportion of the client’s non-recruiting sites. For every
1% improvement in performance, the sponsor will effectively save $1 million.
If Covance were to expedite enrollment timelines, accurately identify favorable sites, and act as a single point-of-contact for
the sites, this would greatly enhance our sponsor’s efficiency and ultimately the satisfaction of patients. Covance not only
provides these services at a comprehensive level, but also initiated a customized approach specifically catered towards this
client. The tailored model was developed to directly address the challenges faced by this sponsor, with a collaborative focus
on continuous feedback and improvement.
CASE STUDY: EXPANDING
PATIENT ENROLLMENT AND
SITE ACTIVATION
Understanding the Situation
Clinical development services are often only partially outsourced. Some sponsors prefer to manage the
trial themselves due to an affinity for the science involved or belief that the trial’s complexity is better
handled internally. For this reason, a flexible partner is ideal to ensure the sponsor’s needs are being
met efficiently and effectively. In 2014, a top-ten pharma sponsor decided to outsource clinical delivery
services due to site management and monitoring (SM&M) challenges in the United States (US). This
sponsor already held significant experience and rapport with Covance in partnering together for central
▶ A need to track and increase patient enrollment
▶ Insufficient tools to ensure activation of the “right” sites
▶ A fragmented operational model with multiple hand-offs
laboratory services, spanning ≥1000 studies. The challenges
this sponsor faced in the clinical space included:
The client’s clinical team wanted complete oversight of
clinical trials but needed assistance in order to identify
investigator sites and sustain enrollment rates. It was
essential to this client that US SM&M deliver more
efficiently to keep up with the demands of their growing
portfolio in a key market, while also strengthening the US
patient pipeline to deliver ≥20% of the patient allocation
within a global program.
▶ Activate sites quickly and efficiently to ensure site activation and enrollment timelines were met
▶ Identify and pursue the optimal sites to meet the US patient target (20% assumed of global patient population)
▶ Act as a single point-of-contact for their sites, including engagement, management and monitoring
▶ Provided ~420 specialized individuals
throughout the duration of the study
▶ Executive and Operational level
governance structures established to
provide oversight
▶ $6 million savings per year by
reducing non-recruiting sites
▶ CTMS compliance exceeded
sponsor’s goal of 96% for past 18
months
▶ 13 of 15 active studies exceeded
required eTMF compliance metric

2. The Tailored Model
The Site Activation Management and Monitoring (SAMM) project was developed as a Functional Service
Provider (FSP) model to leverage our experience with sites and patient enrollment to meet the needs of our
client and ensure successful delivery. Within this model, Covance served as the US SM&M team for all US
insourced studies on behalf of the sponsor.
Applied Approach to Monitoring Success
In order to track portfolio progress and status, critical performance indicators, general study level
performance indicators and portfolio indicators have been agreed upon within the Master Service
Agreement (MSA). Covance SAMM teams provided weekly study level status reports to the sponsor’s
counterparts to ensure that the teams were aware of and confident with the status of progress.
24 SAMM studies were awarded to Covance - 14 in 2015 and 10 in 2016. Of the 14 studies that have
completed enrollment, 6 exceeded the enrollment timeline by an average of 99 days and 8 aligned with
the timeline. The achievements of these studies have further validated the partnership model between
Covance and the sponsor, specifically into the clinical space. The Covance team has successfully tailored
and delivered an effective enrollment process on all SAMM studies to date.
Building Efficiencies and Increased Quality
Throughout the partnership the team continued to build efficiencies and
adapt based upon experiences and lessons learned. It was recognized that
additional stakeholder management from the sponsor’s team members
was needed with Oncology studies. As a result, a detailed communication
plan was put in place with clear communication pathways to provide study
updates, appropriate points of collaboration and issue escalation along with
timely triggers. By defining this path, escalations around risk mitigations
and communications were greatly supported during data sweeps as well as
database locks. The SAMM teams were all successful in meeting locks early or on time for the US.
To maximize the use of our client’s systems, Covance built a Subject Matter Expert (SME) team specifically to support the
Covance project teams. The SMEs were trained by the sponsor’s SuperUsers and became extremely proficient in their
systems, provided ongoing training and guidance to SAMM teams as well as developing internal tools to support quality.
It was noted that there were larger than expected variances in pass through budgets and investigator grants. A financial
reconciliation process was implemented to provide more transparency to the sponsor’s team as well as maintain stability
regarding budget health. The process entailed an ongoing review of variance between contracted budgets, spend to date
and cost to complete for Pass-through costs and Investigator Grants. There is joint agreement between Covance and the
sponsor on principles for managing budgets. There are also established guidelines for management of the variance to
ensure budget variances are within 5% by the end of a study.
While the SAMM partnership between Covance and this client has continued to evolve, there has been significant
progress made which has translated to increased patient enrollment, successful site identification and activation,
streamlined processes and ongoing implementation of best practices and lessons learned.
Learn more about our drug development solutions at www.covance.com
Covance Inc., headquartered in Princeton, NJ, USA, is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is a registered trademark and the
marketing name for Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440
Europe/Africa +00.800.2682.2682 +44.1423.500888
Asia Pacific +800.6568.3000 +65.6.5686588
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Site Activation, Management and Monitoring
Example from a partnership with a top 10 pharma client