Therapeutic Expertise

30+ Product Approvals Supported Across 500+ Studies, Let Our Expertise Help Guide Your Development Strategy

With extensive experience in key therapeutic areas such as oncology, neurology, and ophthalmology SDC aligns its teams therapeutically to ensure we bring this knowledge to the front line of our services.

Since our inception in 2005 SDC has worked across a broad therapeutic spectrum. With extensive experience in oncology, neurology, and ophthalmology SDC aligns its teams therapeutically to ensure we bring this knowledge to the front line of our services. With a deep bench of therapeutic knowledge and a long history of supporting clients at the FDA and other regulatory agencies, SDC works to support data-enabled development of a regulatory strategy that will offer the best opportunity for success.

Ophthalmology

20+ Product Approvals and Counting

Oncology

Supporting the Next Generation of Cancer Therapy Through Thoughtful Guidance

Neurology / CNS

Thoughtful Collaboration with Your Team to Guide Your Development Strategy

Other Therapeutic Areas

Supporting Your Growth and Expansion Needs into All Therapeutic Areas

Therapeutic Area Experience

N

Cardiovascular

N

Dermatology

N

Gastroenterology

N

Hematology

N

Infectious Disease

N

Musculoskeletal

N

Nephrology

N

Neurology

N

Ophthalmology

N

Pulmonary

N

Respiratory

N

Rheumatology

N

Surgical

N

Transplant

N

Urology

Ophthalmology

20+ Product Approvals and Counting

Supporting over 300+ clinical trials in Ophthalmology, SDC has unparalleled experience in designing, building and analyzing ophthalmic clinical trials. From Phase 1 to regulatory submission, SDC’s robust ophthalmic experience is SDC- Empowering Clinical Decisions.

Ophthalmology Experience:

N

Extensive Ophthalmology experience across the SDC project Teams

N

All phases of ophthalmic drug development:

Pilot, pivotal, and post-market device and diagnostic trials, including adaptive trial designs and pooled analysis for data submission
N

20+ Ophthalmology Product Approvals 

N

Frequent interaction with regulatory agencies

N

Supported development of CDISC standards for ophthalmology

Ophthalmic Indications

N

Achromatopsia

N

AMD: Wet & Dry

N

Atopic Keratoconjunctivitis

N

Bacterial Corneal Ulcers

N

Blepharitis

N

Conjunctivitis: Allergic, Bacterial, Viral

N

Contact Lens

N

Contact Lens Solution

N

Corneal Deposit

N

Corneal Incision Sealant

N

Diabetic Macular Edema (DME)

N

Diabetic Retinopathy

N

Dry Eye

N

Glaucoma: Drug, Device

N

Impaired Dark Adaptation

N

Inflammation: Anterior/Posterior Chamber, Post-Operative

N

Inherited Retinal Disease

N

Intraocular Lens: Aspheric, Refractive

N

Leber’s Congenital Amaurosis (LCA)

N

Lid Scrub

N

Meibomian Gland Dysfunction

N

Microkeratome

N

Neurotrophic Keratopathy

N

Ocular & Systemic Safety

N

Ocular Redness

N

Optical Coherence Tomography Device

N

Phacoemulsification

N

Pediatric Cataract

N

Presbyopia

N

Retinal Disease

N

Retinitis Pigmentosa

N

Retinoschisis

N

Specular Microscope

N

Spheric IOL

N

Tonometer

N

Uveitis: Anterior, Posterior

N

Vitreal Detachment

N

X-linked Retinoschisis (XLRS)

Oncology

Supporting the Next Generation of Cancer Therapy Through Thoughtful Guidance

SDC’s dynamic oncology expertise spans various tumor types and oncology indications. 

Oncology Expertise: 

N

Supported over 60+ Oncology studies in last 5 years

N

All Phases and Study Designs:

         Adaptive design, Bayesian analysis, Early phase through global Phase 3 drug studies

N

Frequent interaction with global regulatory agencies

N

10+ regulatory submissions supported

N

Rare disease and pediatric oncology expertise

Oncology Indications

N

Acute Myeloid Leukemia (AML)

N

Advanced Solid Tumors

N

B-Cell Lymphoma

N

Bladder Cancer

N

Bone Marrow Cancers

N

Breast Cancers

N

CHK1 Inhibitors

N

Chronic Lymphocytic Lymphoma (CLL)

N

Colorectal Cancer

N

Endometrial Carcinoma

N

Gastrointestinal Cancer

N

Head and Neck Cancer

N

Hematologic Malignancies

N

Hepatocellular Cancer

N

Hodgkin’s Lymphoma

N

Kidney Cancer

N

Leukemia

N

Liver Cancer

N

Lung Cancer

N

Lung Neuroendocrine Tumors (NET)

N

Melanoma

N

Metastatic Breast Cancer

N

Metastatic Solid Tumors

N

Multiple Myeloma

N

Myelodysplastic Syndrome (MDS)

N

Myelofibrosis

N

Non-Hodgkin’s Lymphoma

N

Non-Small Cell Lung Cancer (NSCLC)

N

Ovarian Cancer

N

Pancreatic Cancer

N

Perivascular Epithelioid Cell Neoplasm (PEComa)

N

Prostate Cancer

N

Recurrent Glioblastoma Multiforme (GBM)

N

Renal Cancer

N

Skin Cancer

N

Small Cell Lung Cancer

N

Soft Tissue Carcinomas

N

Solid Tumors

N

Spinal Tumors

N

Thymus Neuroendocrine Tumors

N

Uveal Melanoma

Neurology / CNS

Thoughtful Collaboration with Your Team to Guide Your Development Strategy

SDC has extensive experience across multiple neurology indications from early phase through pivotal submission studies. With an end-to-end technology suite of solutions and a dedicated experienced team in neurological studies, SDC- Empowering Clinical Decisions.

Neurology Expertise:

N

Actively supporting multiple pharmaceutical and medical device/ diagnostic programs in CNS

N

All Phases and Study Designs including multiple ascending dose, PK, and pivotal submission trials

N

Full Service Clinical Trial Management with extensive neurology experience

Neurology Indications

N

Acute Spinal Cord Injury

N

ADHD: Adult, Adolescent

N

Alzheimer’s Disease

N

Amyotrophic Lateral Sclerosis (ALS)

N

Aneurysm

N

Autism

N

Cervical Spondylotic Myelopathy

N

Chronic Low Back Pain

N

Diabetic Neuropathy

N

Dystonia

N

Fibromyalgia

N

Major Depressive Disorder: Adult, Pediatric

N

Migraine Headache

N

Multiple Sclerosis (MS)

N

Muscular Dystrophy

N

Neurodegenerative Diseases

N

Pain Management

N

Postherpetic Neuralgia

N

Schizophrenia

N

Sleep Disorder

N

Traumatic Brain Injury (TBI)

Other Therapeutic Areas

Supporting Your Growth and Expansion Needs into All Therapeutic Areas

Having supported over 500+ studies since inception, SDC provides you an experienced team and an end-to-end technology suite to support multiple therapeutic areas. Our expertise spans from first-in-human to Phase 4, including supporting 30+ product approvals.

Therapeutic Areas

N

Cardiovascular

N

Dermatology

N

Gastroenterology

N

Hematology

N

Infectious Disease

N

Musculoskeletal

N

Nephrology

N

Neurology

N

Ophthalmology

N

Pulmonary

N

Respiratory

N

Rheumatology

N

Surgical

N

Transplant

N

Urology

See How SDC Can Empower Your Clinical Decisions

Contact us or email info@sdcclinical.com