Outsourcing in Clinical ResearchOutsourcing in Clinical Research-Mansi Gaikwad

“Outsource everything except your soul…” -Tom Peters

Agenda• What is Outsourcing?• Key Areas of Outsourcing• What can be Outsourced?• Why Outsourcing?• Advantages of Outsourcing• Advantages of Outsourcing• Problems with Outsourcing• CROs• Some Tips to Outsourcing

A Working Definition of Outsourcing

VENDOR COMPANYServices

OrganizationLevel

Agreement

ServiceLevel

Agreement

•To delegate (a task, function, or responsibility) to an independentprovider OR To relocate or transfer (jobs) to another labor market

•Outsourcing denotes the continuous procurement of services from a third party, making use of highly integrated processes, organization models and information systems.

• Outsourcing - the strategic use of outside resources to perform activities traditionally handled by internal staff and resources. -Dave Griffiths

Key areas of Outsourcing (Types)

Whole trial/Project Outsourcing- Bundled Services: CRO

Partial Outsourcing:Multiple or single Vendor:

• Site Management (SMO)• Pharmacovigilance• Pharmacovigilance• CDM• Medical Writing• Biostatistics• Regulatory approvals• Software development• Labs/Imaging centers• Material/IP Supply (Logistics)• Equipments maintenance/repair

What can be Outsourced?

Pre-clinical Lead Identification & OptimizationToxicityPharmacological studies

Clinical MonitoringMonitoringSite managementRecruitment services

Project / program managementStudy management

Data management & StatisticsData entryData cleaningData analysis

What can be Outsourced? Cont..• Safety services

– Pharmacovigilance– Laboratory testing services– Special central evaluations such as ECG, MRI, CT– Drug level testing in biological fluids

• Regulatory Services– Creating dossier for regulatory submissions such as IND, NDA,

• Documentation services– Research report writing– Study publications writing– Narratives for Adverse events

• Information technology related services– Electronic data capture services

What can be Outsourced? Cont..

• Manufacturing packing services– Active ingredient manufacturing for testing and trials– Clinical trial packaging and QA services

• Consultancy services– Regulatory consulting– Clinical expertise– Clinical expertise– Medical expertise

• Storage services– Study drug storage– Study sample long term storage– Study documentation storage and archival

Why Outsourcing?• Why Outsource?

– Provide services that are scalable, secure, and efficient, while improving overall service and reducing costs

Reasons for Outsourcing Clinical Trials

• Increasing technology expertise of CROs• Increased Complexity of Regulatory

Submissions• Lessening of the burden on outsourcer, so they can focus on core

competenciescompetencies• Growing Pressures to bring Drugs to the market more quickly

A recent news story suggested that unnecessary clinical trials procedures cost the pharmaceutical industry around US $5 billion a year. One way of cutting down on unnecessary procedures is clinical trial outsourcing, as, if planned and chosen correctly, it can save a company time, effort and money.

• Pharmaceutical companies opt to outsource clinical trial activities to vendors capable of providing bundled services such as regulatory services, clinical data management, medical writing, site management, pharmacovigilance, risk-based monitoring, biostatistics, and protocol development. As a large number of molecules fail during the drug discovery process, outsourcing helps mitigate financial risks.

• Site management, monitoring, and data management are still the most frequently outsourced activities, since the right knowledge and skills are required to carry out these tasks.

Advantages of Outsourcing

Cost Effective

Skilled Expertise

Focus on core

Increased

Improved Customer

Service

Focus on core

competencies

Increased productivity

and Efficiency

Better people

management

Access to world-class solutions

Problems with OutsourcingLoss Of Managerial Control Hidden

CostsThreat to

Security and Confidentiality

Lack of Co-ordination

Quality Problems

Linguistic barriers

Dependency on Service Provider

ordination

CROs• CRO is a person or an organization (commercial, academic, or other) contracted by

the sponsor to perform one or more of a sponsor's trial-related duties and functions. (ICH GCP 1.20)

• Contract Research Organizations (CRO’s) first emerged in the 1980’s to help manage the unpredictability of the peaks and troughs of resource requirements.

• There are over 1,100 CROs in the world.• There are over 1,100 CROs in the world.• E.g. Parexel, Quintiles, ICON, etc• CROs help to decrease the time & money spent in the drug development process.• CROs can deliver value-added in various aspects of the clinical trial process

expertise owing to their Contacts as well as Specializations in different fields.• CRO’s can provide access to specific therapeutic area expertise, geographic

coverage across large parts of the globe and technical expertise in the management of clinical trials.

CROs• The move towards outsourcing has reduced the in-house costs of drug development

procedures from 74% to 62% between 2003 and 2010.• Since pharmaceutical companies need to drive down nearly $1.3 billion in costs and

reduce a 15-year timeframe for bringing a drug to market, outsourcing clinical trials to a number of specialized Contract Research Organizations (CROs) that have expertise and efficiency

• Kalorama Information reports that the portion of drug development research (clinical trial) outsourced to CROs reached $36.6 billion in 2011, up 6.6% annually from $31.8 trial) outsourced to CROs reached $36.6 billion in 2011, up 6.6% annually from $31.8 billion in 2009, and this market is projected to grow to $60.8 billion by 2016.

• In general, CROs allow drug developers to save on the long term expenses of establishing a comprehensive in-house infrastructure for preclinical and/or clinical testing. Overall, CROs are able to shorten clinical testing times by as much as 30%.

(Source: http://www.contractpharma.com/issues/2012-03/view_features/clinical-trial-outsourcing-report)

Lets talk in terms of Numbers….

Research reveals that compared to low CRO usage projects, those with high CRO usage:

• Show a median of 78 days, compared to 98 days, from protocol readiness to First Patient, First Visit (FPFV);

• Reach study data availability from protocol readiness in 196 days vs. 231 days;

(Source: http://www.contractpharma.com/issues/2012-03/view_features/clinical-trial-outsourcing-report)

Some tips to Outsourcing

1. Identify the Company’s needs and choose the best outsourcing model accordingly.

2. Carry out a SWOT Analysis to figure out the risks company can be exposed to.

3. Be Clear on what you want done.4. Create Guidelines or Manuals.4. Create Guidelines or Manuals.5. State your Expectations and explain your terms6. Prepare a detailed contract.7. Request timely reports.8. Find the right people, look for trained professionals.9. Keep the calculation, mode and method of payment easy.10. Utilize Forums and Social Sites wherever possible.

11. Disclose only significant information that is required, and ensure confidentiality where needed.

12. Recognize the time frames for delivering results13. Identify the necessary infrastructure and equipments14. Identify Hidden Costs, and make feasible financial agreements after

due analysis of the expenses.15. Identify the Efficiency & Accuracy (e.g. Biostatistics) of the results.16. Ensure accessibility & Communication with the goods or service 16. Ensure accessibility & Communication with the goods or service

provider.17. Be ready with Damage control procedures or back-up plans.

Thank you…!!

References: SlideshareSlideshare

Clinical Trial Outsourcing ppt – PGDCRM, D. Y. Patil University,http://www.contractpharma.com/issues/2012-03/view_features/clinical-

trial-outsourcing-report