Services > Early Clinical Drug Development

Phase I, First-in-Man, Drug - Drug Interaction studies (DDI) & Bioavailability (BA)/Bioequivalence (BE)

• Access to 640+ beds globally that can accommodate large panels, long institutionalisation and mix population studies
• Phase I (First-in-Human) with extensive monitoring and Bioavailability (BA), Bioequivalence (BE), Pharmacokinetics (PK), Pharmacodynamic (PD), Interaction studies (drug/drug, drug/alcohol), Dose Escalation (SAD/MAD), Safety & Tolerability, Dose Ranging and Vaccine studies
• Extensive experience with a variety of dosage forms including immediate release (IR), controlled release (CR) modified release (MR), extended release (ER), solid oral, oral thin films (OTF), oral dispersible tablets (ODT), sublingual, suppositories, inhalers, injections, patches, suspensions and nasal spray
• A vigorous QC process to ensure data integrity
• Experience in working with a broad variety of therapeutic areas including cardiovascular, infectious diseases, psychiatric, gynaecological, endocrine, neurological, anti-inflammatory, anti-infective, analgesic, gastrointestinal, respiratory, urological and dermatological
• Proximity to emergency facilities
• State-of-the-art emergency and resuscitation equipment
• Dedicated controlled access pharmacy with continuous temperature & humidity monitoring
• Licence to import and secure storage of narcotics & controlled drug substances
• Provide ECGs & EEGs, Pulmonary Function Testing (PFT), Cognitive Drug Testing (CDR), Gastroesophageal monitoring, Cardiac monitoring, Radiology (X-rays, MRIs)
• Clinical team comprised of medical doctors, registered nurses, technicians, and medical assistants

Lambda has the expertise to offer you the entire range of services for First-in-Man and Phase I clinical trials. Our capabilities lie in designing the protocol, conducting the study, generation of the clinical study report and the regulatory submission.

Expertise in conducting Phase I studies in

• Healthy volunteers
• Geriatric population
• Postmenopausal/Surgically sterile women
• Hypertensive patient population
• Asthma patient population
• Patients with renal and hepatic impairment
• Patients with chronic obstructive pulmonary disease
• Type 1 and Type 2 diabetes patients
• Patient population of various cancers

Services

• Phase I studies (First-in-Man)
• Drug-Drug interaction studies
• Drug-Food interaction studies
• Proof of concept studies
• Safety and tolerability studies
• Dose ranging studies
• Early patient studies