Dublin, Dec. 16, 2021 (GLOBE NEWSWIRE) -- The "Site Management Organizations Market by Therapeutic Areas, Trial Phases, Clinical Trial Components, Type of Interventions and Key Geographies: Industry Trends and Global Forecasts, 2021-2035" report has been added to ResearchAndMarkets.com's offering.
This report features an extensive study of the current market landscape and future potential of the site management organizations market. The study features an in-depth analysis, highlighting the capabilities of clinical trial site management service providers engaged in this domain.
Clinical trials form an integral part of the overall drug development process, enabling the necessary evaluation of the safety and efficacy of a drug candidate. Studies suggest that around 40% of the total investment made for the development of drug candidate is dedicated to clinical trials; this is equivalent to an expenditure of USD 78 billion annually. However, the conduct of such trials is often fraught with challenges, including scientific and operational complexity, concerns associated with recruitment and retention of suitable patients, issues related to data handling and increasingly stringent regulatory guidelines.
Further, owing to the inherent complexity of the overall process and involvement of several different stakeholders, these trials are prone to delays. In fact, over 80% of the clinical trials are delayed by at least one to six months, while only 10% of the studies are completed on time. Therefore, innovators in the pharmaceutical industry are constantly developing ways to improve the process of conducting clinical trials and managing research sites.
Amidst other alternatives, outsourcing various trial operations to a specialized service provider, such as site management organizations (SMOs), has emerged as a viable option for various developers. The advantages of engaging such specialized service providers are numerous and enable sponsors to meet their clinical research timelines. In addition, SMOs can facilitate rapid patient recruitment, reduce study timelines, and manage the entire clinical trial processes and administrative work for their clients. Moreover, drug/medical device developers, and even the contract research organizations (CROs), can employ the therapeutic and operational expertise, global site networks and well-established processes and tools offered by SMOs in order to carry out their clinical research and site management activities in a cost and time efficient manner.
Currently, around 250 companies claim to be actively providing clinical site management services to drug and medical device developers across the world. Recently, there has been a lot of activity within the site management market, primarily focused on consolidation of affiliated capabilities, service portfolio expansions and collaborations to extend geographical reach. The aforementioned developments may be attributed to the growing preference for one-stop-shops among sponsor companies, and the gradual acceptance of outsourcing as a viable and beneficial operating model for conducting clinical trials and managing research sites. With the growing complexity, as well as rise in the number of clinical trials being registered, the demand for SMOs is anticipated to grow at a steady pace in the coming years.
Amongst other elements, the report features:
- A detailed review of the overall landscape of companies offering clinical trial site management services to various organizations, including CROs, and pharmaceutical, biotechnology and medical devices companies, along with information on their year of establishment, company size (in terms of employee count), location of headquarters and geographical reach of the companies. The chapter also covers details related to type of service(s) offered (site identification and selection, study feasibility, study protocol development, patient recruitment, patient retention, project management, regulatory support, clinical monitoring, site management, clinical trial data management, patient follow-up, real-time enquiry/information support, study contract, budget and expense management/contract negotiation, hiring/training study investigator, logistics management, quality control and quality assurance and others) and therapeutic expertise of service providers.
- An insightful 22 representation of the competitiveness analysis of various service providers segregated into three peer groups based on location of their headquarters (North America, Europe, and Asia-Pacific and RoW). The companies were further distributed across the geographies, based on their employee count, into three categories, namely small (1-200 employees), mid-sized (201-500 employees) and large (>500 employees), highlighting the top players in this domain, based on their respective capabilities.
- An analysis of the partnerships that have been inked by stakeholders engaged in this domain, during the period 2016-2021 (till August). The various types of partnerships captured in our study include (in alphabetical order) acquisitions, clinical trial agreements, clinical trial site agreements, joint ventures, mergers, product/technology integration agreements, research agreements, service alliances, technology licensing agreements, technology utilization agreements and other related agreements. Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership, focus area and most active players (in terms of number of partnerships). It also highlights the regional distribution of the collaborations.
- A detailed analysis of various investments received by players engaged in this domain during the period 2015-2021 (till August), based on several relevant parameters, such as year of investment, number of funding instances, amount invested, type of funding (grant, seed, venture capital, secondary offering, other equity, debt and others) and type of investor, along with information on the most active players (in terms of number of funding instances and amount raised), most active investors (in terms of number of funding instances) and geographical distribution (in terms of number of funding instances and amount invested).
- An in-depth analysis of completed, ongoing and planned clinical studies during the period 2016-2021 (till August), to present clinical trial key insights, based on several relevant parameters, such as trial registration year, number of enrolled patients, trial status, trial phase, type of sponsor and geographical distribution of number of trials and enrolled patient population.
- An informed estimate of the annual demand for clinical study participants, taking into account the target patient population in ongoing and planned clinical trials, sponsored by both industry and non-industry players.
- Elaborate profiles of prominent players (shortlisted based on a proprietary criterion) that offer various clinical trial site management services, across North America, Europe and Asia-Pacific. Each profile provides an overview of the company, featuring information on the year of establishment, number of employees, location of their headquarters, details related to its site management service portfolio, recent developments, and an informed future outlook.
Key Questions Answered
- Who are the leading players in the clinical trial site management domain?
- What is the relative competitiveness of different site management organizations?
- What type of partnership models are commonly adopted by stakeholders in this industry?
- What is the capital investments trend in site management organizations domain?
- Which are the most active clinical trial centers?
- What are the major market trends and driving factors that are likely to impact the growth of site management organizations market?
- How is the current and future market opportunity likely to be distributed across key market segments?
Key Topics Covered:
1. PREFACE
2. EXECUTIVE SUMMARY
3. INTRODUCTION
4. COMPETITIVE LANDSCAPE
5. COMPANY COMPETITIVENESS ANALYSIS
6. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN NORTH AMERICA
7. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN EUROPE
8. COMPANY PROFILES: SITE MANAGEMENT ORGANIZATIONS IN ASIA-PACIFIC
9. PARTNERSHIPS AND COLLABORATIONS
10. FUNDING AND INVESTMENT ANALYSIS
11. KEY INSIGHTS FROM CLINICAL TRIAL ANALYSIS
12. ANALYSIS OF DEMAND FOR CLINICAL TRIAL PARTICIPANTS
13. MARKET FORECAST AND OPPORTUNITY ANALYSIS
14. CONCLUDING REMARKS
15. EXECUTIVE INSIGHTS
16. APPENDIX 1: TABULATED DATA
17. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS
Companies Mentioned
- 23andMe
- 3H Medi Solution
- 3S Pharma
- Accel Clinical Services
- Accell Clinical Research
- Accelovance
- accerise
- Access Clinical Research
- Ace Research
- ACI Clinical
- Acrostar SMO
- ACTG-CRO
- Advanced Clinical
- Aetion
- Affiliated Clinical Research
- AiCure
- Alpha Oncology Research (AOR)
- Altasciences
- Amadeus Capital Partners
- AmberCRO
- American Liver Foundation
- American Research Associates (ARA)
- AmerisourceBergen
- Analgesic Solutions
- Andronovo Labs
- Anteris Bio
- Antev
- Antidote
- AOBiome Therapeutics
- Apex Medical Research
- APF Research
- ApotheCom
- Apptomics
- Aptitude Health
- Ardent Clinical Research Services
- Asian Eye Institute
- Associated Medical
- Association of Clinical Research Professionals (ACRP)
- AstraZeneca
- Atlant Clinical
- Aurum Clinical Research
- AusTrials
- AutoCruitment
- Avacare
- AXELLE Group
- AXIM Biotechnologies
- BBK Worldwide
- Beijing Aisimo Medical Science and Technology
- Beijing CTSMED
- Beijing EasyTrial MedTech
- Beijing Global Pharmaceutical Research (Acquired by EPS International)
- Beijing Illness Challenge Foundation (ICF)
- Best Clinical Practice
- Bioclinica
- Biomapas
- Biomedical Advanced Research and Development Authority (BARDA)
- Biomic Lifescience
- Biosite Research
- Box
- BrainStorm Cell Therapeutics
- Briban Invest
- Bridge Clinical Research
- BTC Network
- Cactus Clinical Research
- Calmark
- Canadian Centre for Clinical Trials (CCCT)
- Cardialysis
- CaringKind
- Caris Life Sciences
- Carpathian Research
- Catalyst Regulatory Services (Acquired by Veristat)
- CCT Research
- Central India Clinical Research Services (CICRS)
- Centre International de Developpement Pharmaceutique (CIDP)
- Chase Medical Research
- ChiG
- Chrondel
- Cidara Therapeutics
- Cinven
- Clariness
- Cliantha Research
- Clin Sol
- Clinade Clinical Research
- Clinart MENA
- ClinChoice
- ClinEdge
- Clinerion
- Clinexa Life Sciences
- Clinical Accelerator
- Clinical Development Solutions (CDS)
- Clinical Endpoints
- Clinical Investigation Centre (University Malaya Medical Centre)
- Clinical Research Fastrack
- Clinical Research Partners
- Clinical Trial Networking (CT-N)
- Clinical Trials Management Solutions (CTMS)
- ClinicalConnection
- Clinipace
- CLINISYD
- Clinixir
- ClinROtech
- ClinSmart
- Clinsol
- Clinspire Research
- Clintec
- Clintract
- ClinVax
- Clinverse
- ClinWin Research Services
- CLS-Ukraine
- CluePoints
- CMIC Group
- CMX Research
- CNS Pharmaceuticals
- COD Research
- Comac Medical
- COMPASS Pathways
- Compass Research
- Continuum Clinical
- Cosmic Clinical Services
- Credevo
- Crestline Investors
- CRO Pharmatrendz
- Croissance Clinical Research
- CROMSOURCE
- CRS Clinical Research Services
- CTC North
- CTI Clinical Trial and Consulting Services
- CTM
- CX Partners
- Cyclo Therapeutics
- Cytespace
- DAC Patient Recruitment Services
- Datavant
- DAVA Oncology
- DaVita Clinical Research
- Deep Lens
- Deerfield Management
- DEMEDICA
- Devana Solutions
- DFnet
- Dimension Research
- Direct Biologics
- dMed
- Duke Clinical Research Institute (DCRI)
- eClinical Solutions
- Edenwell Therapeutics
- EDETEK
- Effectus CTR
- EGeen
- Elligo Health Research
- EMMES
- emovis
- Empower Capital
- EPS Associates
- EPS International
- EQT
- ERT
- ESTERN Medical
- Estudios Clinicos Latinoamerica (ECLA)
- Ethicscare Clinical Research Services (ECRS)
- EthosExcel
- Everest Clinical Research
- Evolution Research Group (ERG)
- Experior
- F2 Ventures
- FARMEPO
- FDAMap
- Febo
- FedDev Ontario
- FHI Clinical
- Fidelis Research
- FOMAT Medical Research
- Foundation Medicine
- Free to Breathe
- Frenova Renal Research
- Fresenius Medical Care
- Gaea
- Gama CRO
- GB Sciences
- GCP Clinical Studies
- GCP Research
- G CURE Healthcare
- GDD Experts
- Genentech
- General Atlantic
- George Clinical
- GIC
- Global Clinical Trials
- Goldman Sachs Asset Management International (GSAMI)
- Gratisol Labs
- GSK
- GuideStar Research
- Haihe Biopharma
- Hatteras Venture Partners
- Haxon Life Sciences
- Healing Hands Clinical Research Services (HHCRS)
- HealthVerity
- Horizon Research
- Hospital Alemao Oswaldo Cruz
- EI Hospital de Especialidades Teodoro Maldonado Carbo
- Hoth Therapeutics
- hyperCORE International
- I'rom Group
- iCo Therapeutics
- iDD Research Solutions
- IKCON PHARMA
- Illingworth Research Group
- InClin
- Incred CR
- Indian Institute of Clinical Research & Management (IICRM)
- Industrifonden
- Infectious Disease Research Institute (IDRI)
- InformedDNA
- Innoplexus
- Innovaderm
- Innovate Research
- Insignia Clinical Services (ICS)
- INSPIRE
- Integrity Capital Wealth Management
- Inteliquet
- International Research Networks (IRN)
- Intouch Clinical Research Center
- Intrinsic Imaging (Acquired by WCG)
- Invicro
- IPHARMA
- IQVIA
- ITOCHU
- ITOCHU Technology Ventures
- Johnson Clinical Research
- Juno Research
- Karyopharm Therapeutics
- Klinar CRO
- KlinEra
- KMR Group
- Komplett Clinical Research (KCR)
- KPS Clinical Services
- KV Clinical Research Services (KVCR)
- Kyung Hee University Hospital
- LEADS Clinical Research and Bio Services
- Limbix
- Linical Americas
- Link Health
- LITMUS
- LiveRamp
- LMC Manna Research
- Lyft
- MakroCare
- Marshfield Clinic Research Institute
- Mary Bird Perkins Cancer Center
- Mayo Clinic
- med fusion (Acquired by Quest Diagnostics)
- Medable
- MedAvante-ProPhase (Acquired by WCG)
- MEDEX
- Median Technologies
- Medicor Research
- Medicus Alliance
- Medicus Health Partners
- Medidata
- Melanoma Research Alliance
- MENE Health Group
- Merck
- Merck Global Health Innovation Fund (GHI)
- Metrics Champion Consortium (MCC) (Acquired by WCG)
- Mitsui
- MMG
- Molecular Templates
- Montserrat Day Hospitals
- MPM Capital
- MPR Development Group
- MTIP
- Muscular Dystrophy Association (MDA)
- National Cancer Center
- National Institute of Clinical Research (NICR)
- National Taiwan University Hospital (NTUH)
- NeoGenomics
- Newton Clinical Research
- NextPhase Research
- Nomad Life Sciences
- North Estonia Medical Centre
- Novotech
- nRollmed
- Nucleon Therapeutics
- O4 Research
- Oaxaca Site Management Organization (OSMO)
- Octopus Investments
- Octopus Ventures
- Okogen
- OneOncology
- Optimum CRO
- Ora
- Oracle
- orphan reach
- Orphanos
- Ospedale San Raffaele
- P3 Research
- Panthera
- Parallel 6 (Acquired by PRA Health Sciences)
- Parexel
- PAS Research
- PatientPoint
- Peachtree BioResearch Solutions
- Penta ID Innovation
- Pepgra
- Pfizer
- Pharmatech
- Pharm-Olam
- phaware
- Physicians Research Group (PRG)
- Plexus Research
- Polaris Biopharma Consulting
- PPC Group
- PPD
- Prabhans Clinical Services
- Praxis
- Precision for Medicine
- Precision Health
- Prime Site
- Prodia
- Protocol First
- ProTrials Research
- Prudentia
- Psilera
- Puerto Rico Consortium for Clinical Investigation (PRCCI)
- Pulse Clinical Research
- Pusan National University Hospital (PNUH)
- PWNHealth
- QAscent Research Solutions
- QPS
- Quad-C Management
- Quanticate
- Quantime World
- Quest Diagnostics
- Quintessential Solutions
- Ravek
- RealTime Software Solutions
- Red Maple Trials
- RemediumOne
- Research Trials Group
- RESolutions
- Reumalab
- Revive Therapeutics
- Richmond Behavioral Associates (RBA)
- Rock Springs Capital
- Rutherford Health plc
- S4 Research
- Sabre Partners
- Samahitha Research Solutions
- Sandia Clinical Research
- Sanjeevani
- Sanofi
- Santa Maria Gastroenterology
- Scandinavian CRO
- S-Clinical
- SDS Clinical
- Sequoia Capital
- SGS Life Science Services
- Shanghai Shoujia Medical Clinical Research
- SiChaGi Medical Solutions
- SIGAL SMS
- Signify Health
- SitePartner
- Skin Research Institute of Singapore (SRIS)
- Skylight Health
- Smedvig Capital
- SMO - DRA. MARISA VICO
- SMO Clinical Research (SMO-India)
- SMO ClinPlus
- SMO UCT
- SMOconnect
- Smooth Drug Development
- SMO-Pharmina
- Society for Clinical Research Sites
- Solutions OP
- Somaya Research and Health Services
- SoMex Research & Health Organisation
- Sonic Clinical Trials
- Spectral Medical
- Spectrum Clinical Research
- Spero Oncology (Acquired by Veristat)
- SPRI Ukraine
- Springhill Fund
- SQN Clinical
- Statistics Collaborative
- Superstring Capital
- Surescripts
- Syncretic Clinical Research Services
- Syneos Health
- Syntax
- Synteract
- Syreon
- Takeda Pharmaceutical
- Terveystalo
- TFS HealthScience
- Association of Clinical Research Professionals (ACRP)
- The Buffalo-Niagara Clinical Alliance (BNCA)
- The Clinical Trial Company (TCTC) (Acquired by Veristat)
- The Clinic'les
- THREAD
- ThreeWire
- Tigermed
- Tiziana Life Sciences
- Topstone Research
- Total Clinical Trial Management
- Translational Research in Oncology (TRIO)
- Trial Management Group (TMG)
- Trialbee
- TrialSpark
- Trifecta (acquired by WCG)
- TriNetX
- Triumph Research Intelligence (TRI)
- Triumpharma
- United States Department of Defense (DOD)
- uMotif
- Unicorn Protego Site Management Organization (UP SMO)
- United BioSource (UBC)
- University of Yamanshi
- Urgent Care Clinical Trials
- Vector Oncology
- Veeda Clinical Research
- Veeva Systems
- VeraSci
- Veristat
- Vicore Pharma
- Vigilare International
- Viomedo
- Virgo
- Walter and Eliza Hall Institute of Medical Research (WEHI)
- WCCT Global
- WCG
- WCG Avoca
- WCG PharmaSeek
- WindRose Health Investors
- Worldwide Clinical Trials
- WuXi Clinical (a WuXi AppTec Company)
- Xcene Research
- Xylem Clinical Research
- Zagvo Portal
- Zarta Life
- Zosano Pharma
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