Medical Affairs

We offer Medical Affairs services with up-to-date and in-depth knowledge and expertise in therapeutic areas and regulatory requirements.

Our Services

Medical monitoring

Medical team inclusive of therapeutic area specialists provide expertise throughout the study conduct from study designing through establishment of study documents including protocol and allied documents to clinical study report submission, clinical database design, study team training and medical support to the study sites.

Health hazard and risk assessment

To comply with regulatory requirement in terms of quality and safety standards for medicinal products, our medical safety experts with toxicology experience coordinate with sponsor experts to deliver scientifically justifiable and unbiased assessments for hazards and risks fulfilling the benefits over weighing risk.

Clinical trial safety assessment

Clinical trial team including dedicated medical reviewers for study safety assessment empowers the study team for individual case assessment, preparation of SUSAR docket and Analysis of similar events (AOSE).

Clinical data review

Experience team for eligibility review, CRF review, medical query handling, laboratory data review and coding review to ensure quality, consistency and accuracy of clinical trial data.

Medical information

Dedicated customer response team handles the medical inquiries from consumers and healthcare professionals addressing the responses through standard and customized approach.

Safety Monitoring

‌Safety of investigational product is established by Clinical safety physicians through meticulous safety monitoring enabled by designing, implementation of study specific plan with risk based monitoring approach

Scientific review

Our Clinical pharmacologists are dedicated in exploring new target receptors in the scope of repurposing the medicinal products which have high yield in conserving public health

Medical consultancy

Consultancy services based on therapeutic areas and study requirements .

Our advantage

Experienced team

Experience in handling Medical monitoring and support.

Domain knowledge

Regulatory requirements across continental, study types.

Established process

Medical Affairs process in compliance with regulatory requirements.

TECHNOLOGY

latest technology and GDPR compliant tools.