The Clinical Trials Division supports Connecticut Children’s investigators in conducting innovative, high quality, multi-center clinical trials. Our specialized team includes dedicated Clinical Research Nurse Coordinators, Clinical Research Associates, an Investigational Drug Pharmacy Team, and a Clinical Research Lab Coordinator, all experienced in facilitating trials for rare disease, inflammation biology, cancer and blood disorders, and fetal and neonatal medicine. We provide comprehensive support from study start-up through close-out for phase I-IV clinical trials and observational studies for neonates, children, and adolescents through 18 years of age. 

For Research Partners  For Patients & Families 

Our Leadership Team:

Alison Oville, BA, CCRC, CHRC
Director, Clinical Trials Division
aoville [at] connecticutchildrens.org (aoville[at]connecticutchildrens[dot]org) 

Michael Isakoff, MD
Medical Director, Clinical Trials Division
misakoff [at] connecticutchildrens.org (misakoff[at]connecticutchildrens[dot]org) 

Hendriana Nielsen, MCR, RD, RN, BSN, CCRP, CPN
Clinical Research Nurse Manager – Multidivisional Team
hnielsen [at] connecticutchildrens.org (hnielsen[at]connecticutchildrens[dot]org) 

James Santanelli, MS, MPH, CCRP
Lead Clinical Research Associate – Multidivisional Team
jsantanelli [at] connecticutchildrens.org (jsantanelli[at]connecticutchildrens[dot]org) 

Robin Arens, BA, CCRP
Lead Clinical Research Associate – Hematology/Oncology Team
rarens [at] connecticutchildrens.org (rarens[at]connecticutchildrens[dot]org) 

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Why partner with Connecticut Children’s?

We are a free-standing pediatric health care system serving Connecticut, Western Massachusetts and New York with pediatric expertise in over 45 specialties. High skilled, multi-specialty clinical trials team ensuring successful execution of phase I-IV clinical trials and observational studies for neonates, children, and adolescents through 18 years of age. 

Patient Catchment Area 

  • 1.2 m regional population 

Clinical Trials Expertise

  • Rare disease in Endocrinology, Fetal medicine, Neurology 
  • Gastroenterology, Neonatology, Neurosurgery, and Rheumatology 
  • Hematology and Oncology 

Clinical Trial Modalities 

  • Drugs, biologics, devices, gene and cellular therapy

Coming soon (October 1, 2026)

  • Advanced Cellular and Gene Therapy Unit 

Trials conducted (last 5 years) 

  • 424

Population 

 

CardiologyMyocarditis, Pericarditis
EndocrinologyCongenital Adrenal Hyperplasia, Glycogen Storage Disease, Hypophosphatasia, Idiopathic Short Stature, Osteogenesis Imperfecta
Fetal MedicineCongenital Diaphragmatic Hernia, Gastroschisis
GastroenterologyCrohn’s Disease, Irritable Bowel Syndrome, Ulcerative Colitis
HematologyHemophilia, Sickle Cell Disease, von Willebrand disease
NeurologyCharcot Marie-Tooth Disease, Duchenne’s Muscular Dystrophy, Niemann-Pick Disease, Partial Onset Seizures Spinal Muscle Atrophy
NeurosurgeryCerebral Palsy, Spina Bifida
OncologyGliomas, Leukemias and Lymphomas, Medulloblastoma, Neuroblastoma, Sarcomas, Renal Tumors
RheumatologyJuvenile Idiopathic Arthritis

 

Study Start Up 

30 weeks

Key partnerships

  • Established 40 distinct industry partners over the last 5 years
  • Children’s Oncology Group (COG) Member Site 
  • Beat Childhood Cancer (BCC)
  • Moffitt Cancer Center (MCC)
  • Inherited Neuropathy Consortium site

Dedicated research Infrastructure:

  • Dedicated private research infusion clinic rooms within our main hospital
  • Onsite certified research laboratory with same day processing 
  • Institutional IRB oversight
  • Investigational pharmacy
  • Private monitoring rooms
  • E-platforms – Veeva (regulatory), Vestigo (IP), EPIC

Clinical Trials Care Team:

  • Highly experienced clinical trial investigators recognized nationally and internationally
  • ACRP/SOCRA certified Clinical Research Nurse Coordinators and Clinical Research Coordinators
  • Adjacent ancillary services such as Cardiology, Endoscopy, Radiology, Respiratory, PT/OT, Sedation 
  • Dedicated Clinical Research Lab Coordinator and IRB Coordinator
  • Dedicated Investigational Pharmacist
  • Regulatory Manager to ensure an efficient study start-up process

 

How to get in touch with us

Please send your inquiry to our email with all available preliminary information about the trial. We’ll connect you with a physician within that area of expertise within 3 business days.

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Participating in a Clinical Trial

The treatments you and your child benefit from today exist because of clinical trials.

Clinical trials study whether an investigational treatment, such as a medication or gene therapy, is safe and effective for your child’s condition. They provide access to investigational treatments before they’re approved by the Food and Drug Administration (FDA) and help us to better understand different diseases, which treatments are most effective, and contribute to improving children’s health care.

While participating in a clinical trial, your child will be monitored very closely by a physician (also known as the investigator) who is an expert in that field of study, the study team (Clinical Research Nurses and Study Coordinators) and other external regulatory bodies that oversee the study to ensure continued safety.

Your child’s participation in a clinical trial is voluntary, and for some trials, requires your permission as well as your child’s assent to participate. It’s important to talk it through with your child’s doctor and thoroughly review the consent form document that describes the details of the study before making a decision.

Where can I find trials that may benefit my child?

Please send an email. We’ll respond to your question within 3 business days.

You can also search for information about clinical trials at Home | ClinicalTrials.gov.