Comprehensive Clinical Services

2. Clinical Trials

1. Bioequivalence / Bioavailability studies

4. Toxicity study & reports

3. Dossiers (ACTD, CTD, eCTD, as per Sponsor and MoH requiremnets)

6. Medical Transcription & Writing

5. PSUR (Periodic Safety Update Reports)

7. Medical Rational of Drugs

Expertise in Bioequivalence / Bioavailability Studies

Salient features of Clinical Facility :

» A clinic with 38 beds facility and an ICU.
» Separate Screening, Drug storage, entertainment, dining and phlebotomy area.
» A team of GCP-trained professionals.
» Standard Operating Procedures to comply with GCP.
» Independent Ethics Committee.
» Extensive database of subjects.
» Accredited /certified laboratories.

What we do :
» Protocol Development
» CRF Designing
» Statistical Analyses & Interpretations
» Study report generation as per the regulatory requirement.

Design and Conduct of :
» Single Dose / Multiple Dose Studies
» Single Dose Multiple Periods Crossover Studies
» Fasting and/ Fed studies
» In-House and/Ambulatory studies
» Dose Proportionality Studies
» Cross over and/Parallel studies

Salient features of Bio-Analytical Facility :

» LC-MS/MS (API 3200, API 4000, API 4200)
» Well equipped with automated HPLCs
» Solid Phase extraction system
» Refrigerated centrifuge
» -80ºC and -20ºC Deep freezer facility.
» Well qualified and trained scientists

What we do:
» Sample processing
» Method feasibility: Enabling the identification of most appropriate method for the detection of the drug in biological samples
» Method development: Utilizing scientific expertise to develop methods specific for drugs.
» Method validation: In accordance with the regulatory guidelines, validation criteria are compliant, ensuring a robust and reliable assay that delivers sensitivity and selectivity.
» Revalidation of the assay method
» Biological sample analysis of drugs and / or metabolites for pre-clinical and clinical studies
» Stability studies as per ICH guidelines for parameters.

Our clinical researchers, Pharmacokinetics, pharmacologists, statisticians and software specialists design the scientific studies, and they are responsible for the collection and analysis of data in order to evaluate the plasma concentration of the drugs required for regulatory authorities.

Clinical Trials

Key Activities :

» Clinical Trial Services and Consulting (Phase I-IV)
» Site Identification / Investigator Recruitment / Feasibility Assessments
» Study Setup (including investigator/hospital contract management)
» Regulatory and Ethics Committee Submissions.
» Monitoring
» Project Management
» Auditing
» Organizing of Investigator Meetings and Congresses
» Identification of Pre-Clinical and Phase I Units
» Local/Country Specific Lab Identification
» Bio-Medical and Pharmaceutical Research
» Scientific Expertise and Consulting
» Bio-Medical and Pharmaceutical Consulting (including marketing and product registration)
» Veterinary Medicine studies
» Study Design and Protocol Development
» Clinical Trial and Site Management
- Research site selection and evaluation
- Investigators' meetings
- Personnel training
- Site initiation
- Site set-up and training for (EDC) Electronic Data Capture
» Site Monitoring
- Source data validation
- Checking internal consistency of CRF data
- Data query management
- Issuing Data Alerts to CDM
- Monitoring of enrollment rate and patient eligibility criteria
- Drug accountability
- Site closure
» Project Management
- Research site liaison
- Progress and status reports
- Tracking CRFs and DCFs
- Medical monitoring and reporting of Serious Adverse Events
- On-site support and help desk for Study Design
- Phase I/II safety and dose-finding studies
- Phase II exploratory efficacy trials
- Randomized controlled phase III trials
- Phase III and IV trials
- Pharmacokinetic and dynamic studies
- Bio-equivalence and therapeutic equivalence trials
- Pharmacovigilance and pharmacoeconomic trials
» Protocol Development
- Statistical planning (sample size estimation, randomization, and power calculations)
- Complete protocol development
- Case Report Form design
- Literature review and meta-analysis
- CRF completion guidelines
- Client representation or support at regulatory meetings (INDs NDAs)

Regulatory Toxicology

» Regulatory toxicological studies on APIs as per guidelines.
» Acute toxicity studies in mice by oral and parenteral routes of administration.
» A team of GCP-trained professionals.
» Sub-acute Toxicity Studies in rat and mice.
» Chronic Toxicity Studies in rat and mice.
» Primary Skin Irritation Studies in Rabbits.
» Mucous Membrane Irritation Studies in Rabbits.
» Statistical Analyses & Interpretations.
» Study report generation as per the regulatory requirement.


Data Management & Biostatistics

Alpha Laboratories' biostatics and data management department provides impeccable, all-inclusive service to support your project needs, from the initial planning stages through to the final database, statical analysis and reporting.

The department's services include:

» Protocol development
» Statical programming and analyses
» Interpretation and reporting of data for clinical trial reports and publications
» Flexible data-capture capabilities based on specific project requirements validated software for data compilation, review and cleanup.


Regulatory Affairs

The Drug Regulatory Affairs Fairs group offers regulatory services for human and veterinarian medicinal products such as new active ingredients, generics, herbal medicinal products and biotech products.

» Advice on regulatory requirements and application strategies
» Preparation of all parts of a registration dossier
» Compilation of registration dossiers
» Follow-up of submitted documentation
» Dealing with deficiency lists and variations
» Preparation of drug master files
» Applications of certificates of suitability
» Expert opinions and reviews, especially for regulatory compliance
» Medical Writing.

Alpha Laboratories has acquired the experience to create optimal study designs and develop protocols for research programs that extend from dose-finding safety and efficacy studies to large sample-size registration trials and pharmacoeconomic evaluations. Our personnel have the experience and knowledge in all areas of clinical research, biostatistics, and regulatory issues to provide consultative recommendations or lead the design of your study as required.

From protocol design and feasibility assessments through the final study report, clinical research services include global phase I-IV clinical trial management, post-marketing studies, safety surveillance & registries, as well as regulatory and product registration support.