Data Management

Mithas Labs offers integrated data management services in pre-clinical, bio-equivalence, phase I-IV clinical trials, radiology and cardiology. We convert raw data into consistent, accurate, reliable, trial output in compliance with regulatory guidelines. We are dedicated to serve our partners with total commitment to the success of your clinical development program. Our focus is to expedite the regulatory submission process and shorten timelines with out compromising on quality.

Mithas Labs’ services are used by pharmaceutical, biotechnology, device, diagnostic and research organizations. We have the capability to manage multi-centric studies, for domestic and global requirements in different therapeutics areas.

Mithas’ team includes graduates and post graduates in medicine, pharmacy, engineering, science and dental sciences with years of experience in clinical data management. We work in close collaboration with biostatisticians, research coordinators, clinical staff, regulatory and safety teams to ensure timely project deliverables.

Our expertise includes designing, managing and analyzing data from safety, efficacy and epidemiological studies. We can participate directly in your data safety monitoring boards and interact with various partners, including sponsors, health authorities, and other CROs. We have proven processes and systems for managing projects in either your database or our own database.


Biostatistics

Our Biostatisticians have many years of experience to support in all phases of clinical Research. We have the expertise to develop study designs, analysis methods, and interpretations and support the overall clinical development program. Our experienced writers ensure that regulatory submission documents are scientifically as well as medically accurate, and compliant with ICH and regulatory guidelines.

Our Biostatistics services include

	Sample size calculations
	Randomization
	Writing statistical sections of the protocol
	Statistical analysis plan development
	SAS programming for statistical analysis
	Performing analysis
	Delivering statistical reports and clinical study reports

Clinical Information

Our clinical information team consists of experienced professionals who can support the clinical development program to setup trial design, protocol development and medical writing. The clinical study reports generated at Mithas Labs, incorporates all investigators' and client's requirements, while adhering to regulatory authorities and ICH Good Clinical Practice guidance. Our medical writers are know the details of the study to ensure a total understanding of the study. We strive to make our reports insightful, accurate and as per regulatory requirements.


Quality and Project Management

We work with industry-standard data management tools such as Oracle Clinical, SAS, WHO-DD, MedDRA, for consistency and accuracy.

Each project is supported by our integrated quality management systems that ensure the use of standardized processes, technologies and training. We continuously capture and analyze performance metrics to manage complexity through detailed analysis, planning, measurement and management at all stages of project lifecycle.